ML23027A109
| ML23027A109 | |
| Person / Time | |
|---|---|
| Site: | 07003103 |
| Issue date: | 01/27/2023 |
| From: | Schwarz C Louisiana Energy Services, URENCO USA |
| To: | Office of Nuclear Material Safety and Safeguards, Document Control Desk |
| Shared Package | |
| ML23027A108 | List: |
| References | |
| LES-23-026-NRC | |
| Download: ML23027A109 (1) | |
Text
LES-23-026-NRC Attn: Document Control Desk U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 Louisiana Energy Services, LLC NRC Docket No. 70-3103
Subject:
Request for Revision of Wireless Medical Device Authorization
References:
1.
Letter from S. Cowne to NRC Requesting use of a glucose monitor in classified areas dated 11/21/2019 (LES-19-166-NRC) 2.
Letter from J. Zimmerman to W. Padgett approving the use of the wireless medical device in the classified area dated 6/12/2020 (IN 00041-NRC, ML20163A652)
In Reference 1, Louisiana Energy Services, also dba URENCO USA (UUSA) requested approval for use of a wireless medical device in classified areas. NRC approved the request in Reference 2. UUSA requests a revision to that authorization.
The device is a Dexcom G6 Continuous Glucose Monitoring System. Reference 2 contains a stipulation that the device serial number is to be 8KG4HQ. During a review of medical device authorizations, UUSA discovered that the G6 transmitter is normally replaced, at 90 day or less intervals, when the battery life expires (See chapter 13 of ). UUSA expects that when the device is replaced, the new device serial number will not be the same. UUSA requests the serial number stipulation be removed from the Reference 2 authorization.
The authorized individual has not yet used the device with serial number 8KG4HQ. As such, accelerated review and approval of this revision is not necessary.
If you have any questions, please contact Jim Rickman, Senior Licensing Specialist at 575-394-6558.
Respectfully, Chris Schwarz Licensing and Performance Assessment Manager Enclosure
- 1. Dexcom G6 Continuous Glucose Monitoring System User Guide January 27, 2023 Dexcom G6 Continuous Glucose Monitoring System User Guide