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Dexcom Discovery Sensor 1 Pack

FDA UDI

Class II (US FDA UDI)

by Dexcom

Identity

Trade Name
Dexcom Discovery Sensor 1 Pack FDA UDI
Generic Name
Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
Device Name
G6 Discovery Sensor 1pk, US FDA UDI
Model / Reference
STS-DE-001 FDA UDI
Description
G6 Discovery Sensor 1pk, US FDA UDI

Identifiers

Primary DI / UDI-DI
60386270000257 FDA UDI
510(k) Number
DEN170088 FDA UDI
FDA Product Code
QBJ FDA UDI
GMDN Term
Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1355 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Percutaneous interstitial fluid glucose monitoring system, electrochemical

Dexcom Discovery Sensor 1 Pack by Dexcom — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Percutaneous interstitial fluid glucose monitoring system, electrochemical.

Cleared under the same submission

DEN170088 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dexcom

Sources (1)

  • FDA UDI 997f5802-535b-4164-9163-00756a798ff4 35 fields · synced May 30, 2026