Identity
- Trade Name
- Dexcom G5 Mobile Receiver Kit FDA UDI
- Generic Name
- Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
- Device Name
- G5 Mobile Receiver Kit Adult Black FDA UDI
- Model / Reference
- STK-GF-001 FDA UDI
- Description
- G5 Mobile Receiver Kit Adult Black FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10386270000238 FDA UDI
- PMA Number
- P120005 FDA UDI
- FDA Product Code
- MDS FDA UDI
- GMDN Term
- Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not 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
Dexcom G5 Mobile Receiver Kit by Dexcom — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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 III | Pending data |
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Manufacturer
- Manufacturer
- Dexcom
Sources (1)
- FDA UDI 535e5152-3377-4689-a77c-7f686bd354f0 37 fields · synced Jun 1, 2026