Eversense® Smart Transmitter Kit – Provider Purchase FG-3302-01-001

GUDID 00817491022516

Eversense Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense CGM User Guide, Eversense CGM Quick Reference Guide and a wallet card.

SENSEONICS, INCORPORATED

Implantable glucose monitoring system transmitter
Primary Device ID00817491022516
NIH Device Record Key39bc145f-bb8b-4832-a8aa-576ecc32ca8e
Commercial Distribution StatusIn Commercial Distribution
Brand NameEversense® Smart Transmitter Kit – Provider Purchase
Version Model NumberFG-3302-01-001
Catalog NumberFG-3302-01-001
Company DUNS966865636
Company NameSENSEONICS, INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone844-736-7348
Email[email protected]

Operating and Storage Conditions

Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 95 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100817491022516 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QHJSensor, Glucose, Implanted, Non-Adjunctive Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-27
Device Publish Date2019-11-19

Devices Manufactured by SENSEONICS, INCORPORATED

00817491021908 - Eversense® Charging Accessories Pack2019-11-27 Eversense® Charging Accessories Pack contains the Charging Cradle, US Configuration Power Supply and a USB Cable.
00817491021458 - Eversense® Smart Transmsitter Kit - Retail2019-11-27 Eversense Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense CGM User Guide, Eversense CGM Quick Reference Guide and a wallet card.
00817491021403 - Eversense® Insertion Tools Tray2019-11-27 Eversense Insertion Tools Kit includes the Insertion Tool, Blunt Dissector, incision template and instructions for Sensor insertion and removal.
00817491021397 - Eversense® Insertion Tools Kit2019-11-27 Eversense Insertion Tools Kit includes the Insertion Tool, Blunt Dissector, incision template and instructions for Sensor insertion and removal.
00817491021335 - Eversense® Adhesive Patches, 10-pack Clear2019-11-27 Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin.
00817491021311 - Eversense® Adhesive Patches, 3 30-pack White and 1 10-pack Clear2019-11-27 Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin.
00817491021304 - Eversense® Adhesive Patches, 30-Pack White2019-11-27 Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin.
00817491021328 - Eversense® Adhesive Patches, 30-Pack Clear2019-11-27 Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin.

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