AccessGUDID - DEVICE: Eversense® Mobile App iOS (00817491020819)

GUDID

Device Identifier (DI) Information

Brand Name: Eversense® Mobile App iOS
Version or Model: FG-5500-01-300
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: FG-5500-01-300
Company Name: SENSEONICS, INCORPORATED

Primary DI Number: 00817491020819
Issuing Agency: GS1
Commercial Distribution End Date: December 02, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 966865636 *Terms of Use

Device Description: Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.

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":	No
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?
61915	Implantable glucose monitoring system	An assembly of portable, battery-powered devices intended to continuously monitor interstitial-fluid glucose concentrations in a patient with diabetes mellitus, using an invasive technique. It typically consists of a sterile, subcutaneously-implanted sensor with dedicated implantation devices (e.g., blunt dissector, introducer needle), and an externally worn transmitter which communicates with a monitor or receiver (not included) that captures, stores, and converts the sensor signals to glucose concentrations for display. The system aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments.	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: 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: 66a36483-328d-43cd-8dc5-70e4551e5378
Public Version Date: March 11, 2022
Public Version Number: 2
DI Record Publish Date: July 16, 2018