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Dexcom G4 PLATINUM Replacement Receiver with Share Kit US
FDA UDIClass III (US FDA UDI)
by Dexcom
Identity
- Trade Name
- Dexcom G4 PLATINUM Replacement Receiver with Share Kit US FDA UDI
- Generic Name
- Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
- Device Name
- G4 PLATINUM Replacement Receiver with Share Kit US Adult Blue FDA UDI
- Model / Reference
- STR-DR-BLU FDA UDI
- Description
- G4 PLATINUM Replacement Receiver with Share Kit US Adult Blue FDA UDI
Identifiers
- Catalog Number
- STR-DR-BLU FDA UDI
- Primary DI / UDI-DI
- 30386270000171 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 Replacement Receiver with Share Kit US 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 8448f2a1-1f85-488a-a33d-61dafdc77287 38 fields · synced May 30, 2026