AccessGUDID - DEVICE: Eversense E3 Smart Transmitter Kit

GUDID

Device Identifier (DI) Information

Brand Name: Eversense E3 Smart Transmitter Kit - Provider Purchase
Version or Model: FG-5902-01-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FG-5902-01-001
Company Name: SENSEONICS, INCORPORATED

Primary DI Number: 00817491022936
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 966865636 *Terms of Use

Device Description: Eversense E3 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense E3 CGM User Guide, Eversense E3 CGM Quick Reference Guide, and a wallet card.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61912	Implantable glucose monitoring system transmitter	A body-worn, battery-powered component of an implantable glucose monitoring system designed to wirelessly transmit glucose measurements continuously from the implanted sensor to a receiver (e.g., a mobile device). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QHJ	Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P160048	016

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 32 and 95 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a5a1cd74-44e5-444a-97ce-634fd3dcfe4c
Public Version Date: March 18, 2022
Public Version Number: 1
DI Record Publish Date: March 10, 2022