Identity
- Trade Name
- Dexcom Receiver Kit (Medicare) FDA UDI
- Generic Name
- Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
- Device Name
- Dexcom Receiver Kit (Medicare) FDA UDI
- Model / Reference
- STK-MD-001 FDA UDI
- Description
- Dexcom Receiver Kit (Medicare) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00386270000859 FDA UDI
- PMA Number
- P120005 FDA UDI
- FDA Product Code
- PQF 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
Yes
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
Category: Percutaneous interstitial fluid glucose monitoring system, electrochemical
Dexcom Receiver Kit (Medicare) by Dexcom — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Percutaneous interstitial fluid glucose monitoring system, electrochemical.
- Simplera Sync™ — MEDTRONIC MINIMED, INC. · Class III
- Simplera Sync™ — MEDTRONIC MINIMED, INC. · Class III
- Guardian™ Transmitter Kit — MEDTRONIC MINIMED, INC. · Class III
- MiniLink® — MEDTRONIC MINIMED, INC. · Class III
- Bigfoot Unity Diabetes Management System — BIGFOOT BIOMEDICAL, INC. · Class II
- Medtronic MiniLink® — MEDTRONIC MINIMED, INC. · Class III
- Guardian™ Link (3) — MEDTRONIC MINIMED, INC. · Class III
- CGMS® iPro™ — MEDTRONIC MINIMED, INC. · Class III
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dexcom
Sources (1)
- FDA UDI 9d87bc2a-c1a1-46b7-bff4-8252fcd7301e 36 fields · synced May 30, 2026