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Stelo Glucose Biosensor (2pk)

FDA UDI

Class II (US FDA UDI)

by Dexcom

Identity

Trade Name
Stelo Glucose Biosensor (2pk) FDA UDI
Generic Name
Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
Device Name
Stelo Glucose Biosensor US (2pk) FDA UDI
Model / Reference
STP-XN-002 FDA UDI
Description
Stelo Glucose Biosensor US (2pk) FDA UDI

Identifiers

Primary DI / UDI-DI
00386270004383 FDA UDI
510(k) Number
K234070 FDA UDI
FDA Product Code
SAF 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Percutaneous interstitial fluid glucose monitoring system, electrochemical

Stelo Glucose Biosensor (2pk) 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

K234070 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 05c3dd3d-6ee6-465c-8ea2-2b4f70e3dd26 35 fields · synced Jun 8, 2026