AccessGUDID - DEVICE: Eversense Power Adapter (00817491023858)

GUDID

Device Identifier (DI) Information

Brand Name: Eversense Power Adapter
Version or Model: FG-6000-01-303
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N/A
Company Name: SENSEONICS, INCORPORATED

Primary DI Number: 00817491023858
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 966865636 *Terms of Use

Device Description: Power Adapter (i.e., wall plug)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c5383124-f3ce-413b-a9e3-d3fc9f8e4524
Public Version Date: December 13, 2023
Public Version Number: 1
DI Record Publish Date: December 05, 2023