Identity
- Trade Name
- Stelo Biosensor FDA UDI
- Generic Name
- Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
- Device Name
- Stelo Biosensor FDA UDI
- Model / Reference
- 9500-174 FDA UDI
- Description
- Stelo Biosensor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00386270004338 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Percutaneous interstitial fluid glucose monitoring system, electrochemical
Stelo Biosensor by Dexcom — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Percutaneous interstitial fluid glucose monitoring system, electrochemical.
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- Medtronic MiniLink® — MEDTRONIC MINIMED, INC. · Class III
- Guardian™ Link (3) — MEDTRONIC MINIMED, INC. · Class III
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Cleared under the same submission
K234070 also covers:
- Dexcom Stelo Android Mobile App — Dexcom
- Dexcom Stelo iOS Mobile App — Dexcom
- Dexcom Stelo iOS Watch App — Dexcom
- Stelo Glucose Biosensor (1pk) — Dexcom
- Stelo Glucose Biosensor (1pk) UPC — Dexcom
- Stelo Glucose Biosensor (2pk) — Dexcom
- Stelo Glucose Biosensor (2pk) — Dexcom
- Stelo Glucose Biosensor (2pk) UPC — Dexcom
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dexcom
Sources (1)
- FDA UDI e61da9d5-2bf0-47ef-9f0b-fcf2574b129e 35 fields · synced May 30, 2026