AccessGUDID - DEVICE: Eversense® Smart Transmsitter Kit

GUDID

Device Identifier (DI) Information

Brand Name: Eversense® Smart Transmsitter Kit - Retail
Version or Model: FG-3301-01-001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: FG-3301-01-001
Company Name: SENSEONICS, INCORPORATED

Primary DI Number: 00817491021458
Issuing Agency: GS1
Commercial Distribution End Date: June 20, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 966865636 *Terms of Use

Device Description: Eversense Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense CGM User Guide, Eversense 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
QCD	Continuous Glucose Monitor, Implanted, Adjunctive Use
QHJ	Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P160048	000

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: 95058c2d-df78-4fb8-9b14-e313f4fa055a
Public Version Date: June 21, 2023
Public Version Number: 3
DI Record Publish Date: July 16, 2018