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Dexcom G4 Platinum Receiver Kit (Retail)
FDA UDIClass III (US FDA UDI)
by Dexcom
Identity
- Trade Name
- Dexcom G4 Platinum Receiver Kit (Retail) FDA UDI
- Generic Name
- Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
- Device Name
- G4 Platinum Receiver Kit (Retail) Adult Black FDA UDI
- Model / Reference
- STK-RX-001 FDA UDI
- Description
- G4 Platinum Receiver Kit (Retail) Adult Black FDA UDI
Identifiers
- Primary DI / UDI-DI
- 30386270000065 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 G4 Platinum Receiver Kit (Retail) 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 9c06fa35-3951-4f18-959e-ede168934b80 37 fields · synced May 30, 2026