Identity
- Trade Name
- Dexcom G7 GSS (160) FDA UDI
- Generic Name
- Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
- Device Name
- G7 US DME Sensor/Transmitter 1-pack FDA UDI
- Model / Reference
- STP-AT-011 FDA UDI
- Description
- G7 US DME Sensor/Transmitter 1-pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00386270003591 FDA UDI
- 510(k) Number
- K213919 FDA UDI
- FDA Product Code
- QBJ FDA UDI
- GMDN Term
- Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1355 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Percutaneous interstitial fluid glucose monitoring system, electrochemical
Dexcom G7 GSS (160) by Dexcom — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Percutaneous interstitial fluid glucose monitoring system, electrochemical.
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- 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
K213919 also covers:
- Dexcom G7 AR Overlay 10-Pack — Dexcom
- Dexcom G7 Android App — Dexcom
- Dexcom G7 GSS — Dexcom
- Dexcom G7 GSS — Dexcom
- Dexcom G7 GSS — Dexcom
- Dexcom G7 GSS — Dexcom
- Dexcom G7 GSS (151) — Dexcom
- Dexcom G7 GSS (155) — Dexcom
- Dexcom G7 GSS (155) — Dexcom
- Dexcom G7 GSS (160) — Dexcom
- Dexcom G7 GSS (160) — Dexcom
- Dexcom G7 Overpatch 10 Pack — Dexcom
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 II | Pending data |
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Manufacturer
- Manufacturer
- Dexcom
Sources (1)
- FDA UDI 99314e12-b0c2-481b-87bc-77e3128f0773 35 fields · synced Jun 8, 2026