Eversense® Pouch Containing Sensor and Holder N/A

GUDID 00817491022363

Eversense Pouch contains one Eversense Sensor in a Sensor holder.


Implantable glucose monitoring system sensor
Primary Device ID00817491022363
NIH Device Record Key78b0c496-37ee-4ed8-b42e-53971dc8c0e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameEversense® Pouch Containing Sensor and Holder
Version Model Number102095-67A
Catalog NumberN/A
Company DUNS966865636
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

Email[email protected]

Operating and Storage Conditions

Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100817491022363 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QCDContinuous Glucose Monitor, Implanted, Adjunctive Use


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® Pouch Containing Sensor and Holder]

00817491021434Eversense Pouch contains one Eversense Sensor in a Sensor holder.
00817491022363Eversense Pouch contains one Eversense Sensor in a Sensor holder.

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