Eversense® Sensor Kit FG-4200-00-301

GUDID 00817491022349

Eversense Sensor Kit contains one Eversense Sensor.

SENSEONICS, INCORPORATED

Implantable glucose monitoring system sensor
Primary Device ID00817491022349
NIH Device Record Key5c61ca67-601d-4c38-9104-ff43691e5ca4
Commercial Distribution StatusIn Commercial Distribution
Brand NameEversense® Sensor Kit
Version Model NumberFG-4200-00-301
Catalog NumberFG-4200-00-301
Company DUNS966865636
Company NameSENSEONICS, INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone844-736-7348
Email[email protected]

Operating and Storage Conditions

Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100817491022349 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QCDContinuous Glucose Monitor, Implanted, Adjunctive Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-27
Device Publish Date2019-02-06

On-Brand Devices [Eversense® Sensor Kit]

00817491021410Eversense Sensor Kit contains one Eversense Sensor.
00817491022349Eversense Sensor Kit contains one Eversense Sensor.

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.