Identity
- Trade Name
- Dexcom Studio FDA UDI
- Generic Name
- Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
- Device Name
- Dexcom Studio Bundle FDA UDI
- Model / Reference
- MT21190 FDA UDI
- Description
- Dexcom Studio Bundle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10386270000146 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
- 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Percutaneous interstitial fluid glucose monitoring system, electrochemical
Dexcom Studio by Dexcom — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 17055367-10e3-4d52-ace5-7a47e2b3e3db 35 fields · synced May 30, 2026