AccessGUDID - DEVICE: Eversense® Sensor Kit (00817491021410)

GUDID

Device Identifier (DI) Information

Brand Name: Eversense® Sensor Kit
Version or Model: FG-4200-00-301
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: FG-4200-00-301
Company Name: SENSEONICS, INCORPORATED

Primary DI Number: 00817491021410
Issuing Agency: GS1
Commercial Distribution End Date: February 08, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 966865636 *Terms of Use

Device Description: Eversense Sensor Kit contains one Eversense Sensor.

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:	Yes
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?
61930	Implantable glucose monitoring system sensor	A sterile device intended to be implanted subcutaneously for continuous monitoring of glucose levels in interstitial fluid, typically for detecting trends and tracking patterns in patients with diabetes mellitus. It is a small, rod-shaped sensor consisting of an electrochemical or optical glucose detector that emits signals which are sent to an externally-worn transmitter (not included) via a wireless connection. It is passively-powered by the transmitter. Dedicated implantation devices (e.g., blunt dissector, cannula) may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
QCD	Continuous Glucose Monitor, Implanted, 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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 36 and 46 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d79e8dee-dd3a-4c0a-a4a6-86548ad2f908
Public Version Date: February 08, 2019
Public Version Number: 2
DI Record Publish Date: July 16, 2018