Eversense® Sensor Kit - Retail FG-4201-00-301

GUDID 00817491022356

Eversense Sensor Kit contains one Eversense Sensor.

SENSEONICS, INCORPORATED

Implantable glucose monitoring system sensor
Primary Device ID00817491022356
NIH Device Record Keyfa589b02-5b8a-4659-90ba-5a7ac380353f
Commercial Distribution StatusIn Commercial Distribution
Brand NameEversense® Sensor Kit - Retail
Version Model NumberFG-4201-00-301
Catalog NumberFG-4201-00-301
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
GS100817491022356 [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 - Retail]

00817491021427Eversense Sensor Kit contains one Eversense Sensor.
00817491022356Eversense Sensor Kit contains one Eversense Sensor.

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