2ATMC-IDA01USPrimary Medication Line Safety Device

Open Here 1 3 Light on = ok to use Primary Medication Line Safety Device FOR PATIENT SAFETY this product is intended for use with primary medication line only. Attach MedLite ID to primary medication line prior to connecting IV to patient. Inspect tubing for twists or kinks, then close the clamshell door until it clicks. Open the MedLite ID package and remove the three devices from the pack. Removing plastic strip will activate device. Warning ! xxxxxxxxxxxxxx YYYY-MM-DD UPC QTY: 3 REF LOT Manufactured for MedLite ID UT USA Manufactured by ATL XXXX (location) 2 4 Press one of the attached devices to activate the lights for all three devices within a given set. Single Use NON STERILE Prior to connecting the primary medication line to the patient, apply MedLite ID devices (see figure) by running the infusion tubing through the tubing grooves on the device. To maintain proper flow check for pinched or twisted tubing before closing clamshell. Warning ! Drip chamber IV bag Patient Placement Guide Below infusion pump or middle of IV line if gravity set Venous access catheter 1 2 3 Directions Open the MedLite ID peel pack and remove the three devices from the pack. Prior to connecting the primary medication line to patient, apply a MedLite ID device below the drip chamber, at the primary medication injection site and near attachment of the venous access catheter (see figure) by running the infusion tubing through the tubing grooves on the device. Inspect tubing for twists or kinks, then close the clamshell door until it clicks. The MedLite ID device has two forms of identification for the medication line, the attached device itself and an activated light as well. To activate, press one of the attached devices on the circular squeeze point. This will activate the lights for all three devices within a given set. The devices will turn off after about 45 seconds. Pressing on any of the devices will turn all devices back on. The devices are for one infusion set use and should be disposed of when tubing is changed or treatment completed. Warning and Disclaimer This device should be installed by a medical professional. Do not use any component of the device if the product packaging is damaged or opened. MedLite ID is not responsible for use of the product taken from deteriorated packaging or used on non-medication intravenous lines. MedLite, ID is a single use device with multiple components. Never reuse any portion of the device, even if the device appears undamaged. All portions of the device should be discarded when tubing is changed, or the treatment completed. Care must be taken after opening the device to protect from damage to the components. Prior to installation, all portions of the device must be verified to be in good working order. If any portion of these instructions are disregarded, the medical professional and their respective employers, agents, members, managers, partners, officers, affiliates, parent entities, assigns, and all other persons or entities who may be responsible for the disregard assume the risk of the use of the product. Changes or modification to this unit not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. By using this product, it is presumed that this warning and disclaimer has been read and understood. For further information or to share comments or complaints about this product, please visit www.medliteid.com. RF Exposure Information This equipment complies with FCC/ISED radiation exposure limits set forth for an uncontrolled environment. In order to avoid the possibility of exceeding the FCC/ISED radio frequency exposure limits, human proximity to the antenna shall not be less than 20 cm during normal operation. 1 2 3 4 FOR PATIENT SAFETY this product is intended for use with primary medication line only. Warning ! Warning ! Patents: medliteid.com/patents Attach MedLite ID to primary medication line prior to connecting IV to patient. To prevent reduced or obstructed infusion set flow, be sure that when closing the MedLite ID clamshell over the primary medication line that the tubing is not pinched or twisted. This device complies with Part 15 of the FCC Rules and this device also contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation,Science and Economic Development Canada’s licence-exempt RSS(s). Operation is subject to the following two conditions: (1)this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that maycause undesired operation. Contact:US www.medliteid.com EU www.medliteid.com FCC ID: 2ATMC-IDAO1US IC: 26774-IDA01US HVIN: IDA01US IFU: 02.25.2021 - v7.9 Avertissement Les changements ou modifications de cette unité qui ne sont pas expressément approuvés par la partie responsable de la conformité pourraient rendre caduque l'autorité de l'utilisateur pour faire fonctionner l'équipement. Informations sur l'exposition aux RF: Cet équipement est conforme aux limites d'exposition aux rayonnements RSS-102 définies pour un environnement non contrôlé. Afin d'éviter la possibilité de dépasser les limites d'exposition aux fréquences radio RSS-102, la proximité humaine de l'antenne ne doit pas être inférieure à 20 cm en fonctionnement normal. Cet appareil contient également des émetteurs / récepteurs exempts de licence qui sont conformes aux RSS exemptes de licence d'Innovation, Sciences et Développement économique Canada: (1) cet appareil ne doit pas provoquer d'interférences nocives et (2) cet appareil doit accepter toute interférence reçue, y compris les interférences susceptibles de provoquer un fonctionnement indésirable. FCC ID: 2ATMC-IDAO1US IC: 26774-IDA01US HVIN: IDA01US Contact:US/CA www.medliteid.com EU www.medliteid.com

1100 E Chalk Creek Road, Coalville, UT 84107 Page 1 of 1 Request for Confidentiality Date: March 7, 2021 Subject: Confidentiality Request for: FCC ID: 2ATMC-ID01US and IC: 26774-IDA01US_ Pursuant to FCC 47 CFR 0.457(d) and 0.459 and IC RSP-100, Section 12.4, the applicant requests that a part of the subject FCC application be held confidential. Type of Confidentiality Requested Exhibit ☐ Short Term  Permanent Block Diagrams ☐ Short Term External Photos ☐ Short Term ☐ Permanent * 1 Internal Photos ☐ Short Term  Permanent Operation Description/Theory of Operation ☐ Short Term  Permanent Parts List & Placement/BOM ☐ Short Term ☐ Permanent Tune-Up Procedure ☐ Short Term  Permanent Schematics ☐ Short Term Test Setup Photos ☐ Short Term ☐ Permanent * 3 User’s Manual _MedLite ID Inc._ has spent substantial effort in developing this product and it is one of the first of its kind in industry. Having the subject information easily available to "competition" would negate the advantage they have achieved by developing this product. Not protecting the details of the design will result in financial hardship. Permanent Confidentiality: The applicant requests the exhibits listed above as permanently confidential be permanently withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Short-Term Confidentiality: The applicant requests the exhibits selected above as short term confidential be withheld from public view for a period of _N/A__ days from the date of the Grant of Equipment Authorization and prior to marketing. This is to avoid premature release of sensitive information prior to marketing or release of the product to the public. Applicant is also aware that they are responsible to notify ACB in the event information regarding the product or the product is made available to the public before the requested period has expired. ACB will then release the documents listed above for public disclosure pursuant to FCC Public Notice DA 04-1705. NOTE for Industry Canada Applications: IC currently only distinguishes Permanent Confidentiality exhibits as shown above. Short Term confidentiality is not considered applicable to IC applications. Sincerely, By: Agent for MedLite ID Inc Colonel Lister (Les) Payne III (Signature/Title) (Print name) 1 - The asterisked items (*) require further information to be provided to ACB before permanent confidentiality will be extended to these exhibits. Please refer to FCC KDB 726920 and the specific Document link for D01 found at: https://apps.fcc.gov/oetcf/kdb/forms/FTSSearchResultPage.cfm?switch=P&id=41731 and review section II, 3) regarding specific information that must accompany these requests.

9 Feb 2021 Atten:Director of Certification American Certification Body, Inc. 6731 Whittier Avenue, Suite C110 McLean, VA 22101 To Whom It May Concern MedLite ID Inc is submitting the following product which shall contain an unlicensed radio transmitting device subject to US CFR 47 Part 15.231 Rules and Regulations and shall bear the FCC ID: 2ATMC-IDA01US Model: 2ATMC-IDA01US Les Payne (Agent for MedLite ID Inc) Facility Manager DNB Engineering Inc 1100 E Chalk Creek Road Coalville, UT 84017

External Photograph - Back External Photograph - Front

FCC ID Placement

Internal Photographs - Front Internal Photograph - Back Internal Photograph - close up on transmitter section and antenna

Application for Certification For a Transmitter. MedLite ID Inc. Atwood Innovation Plaza, Suite 108 453 S 600 E St George, UT 84770 Medical Device Periodic Transmitter M/N: IDA01US FCC ID: 2ATMC-IDA01US IC : 26774-IDA01US REPORT # UT16044A-001 This report was prepared in accordance with the requirements of the FCC Rules and Regulations Part 2, Subpart J, 2.1033, Part 15.231, RSS-210 Issue 10, and other applicable sections of the rules as indicated herein. Prepared By: DNB Engineering, Inc. 1100 E Chalk Creek Road Coalville, UT 84017 29 Jan 2021 TABLE OF CONTENTS Paragraph numbers in this report follow the application section numbers found in the FEDERAL COMMUNICATIONS COMMISSION Rules and Regulations, Part 2, Subpart J for Certification of electronic equipment. TABLE OF CONTENTS................................................................................................................2 1.0ADMINISTRATIVE DATA...................................................................................3 1.1Certifications and Qualifications............................................................................3 1.2Measurement Repeatability Information.................................................................3 1.3Test Equipment List................................................................................................4 1.4Test Summary Cross Reference..............................................................................5 1.5Measurement Uncertainty.......................................................................................5 2.1033 (b,2)FCC Identifier.........................................................................................................7 RSS-Gen 4.2ISED Identifier........................................................................................................8 2.1033 (b,4)Brief Description of Circuit Function.....................................................................9 2.1033 (b,5)Block Diagram........................................................................................................9 2.1033 (b,7)Equipment Photographs..........................................................................................9 2.1033 (b,6)Report of Measurements ......................................................................................10 15.203Antenna Requirement ..................................................................11 15.207Conducted Emissions - Not Applicable - Battery Operated ........12 15.209Radiated Emissions (General Provisions) ....................................13 15.231 (b)Field Strength Limits - Fundamental............................................16 15.231 (b)Field Strength Limits - Spurious...................................................18 15.231 (a)Dwell Time...................................................................................23 15.231 (c)20 dB Bandwidth..........................................................................25 RSS-Gen 6.799% Occupied Bandwidth............................................................27 15.205Restricted Bands...........................................................................29 End of Report UT16044A-001.....................................................................................................37 Page 2 of 37 1.0ADMINISTRATIVE DATA 1.1Certifications and Qualifications I certify that DNB Engineering, Inc conducted the tests performed in order to obtain the technical data presented in this application. Also, based on the results of the enclosed data, I have concluded that the equipment tested meets or exceeds the requirements of the Rules and Regulations governing this application. 1.2Measurement Repeatability Information The test data presented in this report has been acquired using the guidelines set forth in FCC Part 2.1031 through 2.1057, Part 15. The test results presented in this document are valid only for the equipment identified herein under the test conditions described. Repeatability of these test results will only be achieved with identical measurement conditions. These conditions include: The same test distance, EUT Height, Measurement Site Characteristics, and the same EUT System Components. The system must have the same Interconnecting Cables arranged in identical placement to that in the test set-up, with the system and/or EUT functioning in the identical mode of operation (i.e. software and so on) as on the date of the test. Any deviation from the test conditions and the environment on the date of the test may result in measurement repeatability difficulties. All changes made to the EUT during the course of testing as identified in this test report must be incorporated into the EUT or identical models to ensure compliance with the FCC regulations. C. L. Payne III (Para. 1.1) Facility Manager Coalville Facility. DNB Engineering, Inc. Tel. (435) 336-4433 FAX (435) 336-4436 Page 3 of 37 1.3Test Equipment List TEST EQUIPMENT LIST - CONDUCTED EMISSIONS DescriptionManufacturerModel No.Asset #Serial #Cal Due LISN Fisher Custom Communications FCCLISN5032401U-286202003 Feb 2021 Spectrum Analyzer Rhode & SchwarzFSV30U-24810136727 Aug 2021 TILE Software ETS Lindgren3.4.11.13U-317811200607 Mar 2021 TEST EQUIPMENT LIST - RADIATED EMISSIONS DescriptionManufacturerModel No.Asset #Serial #Cal Due Pre-AmplifierHewlett Packard8447DU-0682727A0618404 Aug 2021 Pre-AmplifierDNBS-21GU-095U-095-103 Feb 2021 BiConiLog AntennaETS - Lindgren3142EU-255154973 03 Sep 2021 DRG Horn AntennaAH SystemsSAS-571U-07141711 Jul 2021 Spectrum Analyzer Rhode & SchwarzFSV30U-24810136727 Aug 2021 TILE SoftwareETS- Lindgren3.4.11.13U-317811200607 Mar 2021 TEST EQUIPMENT LIST - ANTENNA CONDUCTED DescriptionManufacturerModel No.Asset #Serial #Cal Due Spectrum Analyzer Rhode & SchwarzFSV30U-24810136727 Aug 2021 Page 4 of 37 1.4Test Summary Cross Reference Test ItemFCC RequirementIC RequirementTest MethodResult Antenna Requirement 15.203 RSS-Gen 6.8---Pass Con…

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Test Set Up Photograph - Radiated - 30 to 1000MHz Test Set Up Photograph - Radiated - Above 1000MHz Test Set Up Photograph - X-Axis Test Set Up Photograph - Y-Axis Test Set Up Photograph - Z-Axis Test Set Up Photograph - Antenna Conducted Measurments Test Set Up Photograph - Frequency Stability