Identity
- Trade Name
- Livongo Replacement Device FDA UDI
- Generic Name
- Glucose analyser IVD, home-use FDA UDI
- Device Name
- Livongo Blood Glucose Meter BG300, Charger, Charger Cable, 1 User Guide (English), 1 User Guide (Spanish) FDA UDI
- Model / Reference
- Livongo FDA UDI
- Description
- Livongo Blood Glucose Meter BG300, Charger, Charger Cable, 1 User Guide (English), 1 User Guide (Spanish) FDA UDI
Identifiers
- Catalog Number
- KIT01595 FDA UDI
- Primary DI / UDI-DI
- 00853553005417 FDA UDI
- 510(k) Number
- K133584 FDA UDI
- FDA Product Code
- NBW FDA UDI
- GMDN Term
- Glucose analyser IVD, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 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
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Category: Glucose analyser IVD, home-use
Livongo Replacement Device by Livongo Health, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K133584 also covers:
- Livongo Blood Glucose Meter — LIVONGO HEALTH, INC
- Livongo Blood Glucose Meter — LIVONGO HEALTH, INC
- Livongo Blood Glucose Meter — LIVONGO HEALTH, INC
- Livongo Blood Glucose Meter — LIVONGO HEALTH, INC
- Livongo Control Solution — LIVONGO HEALTH, INC
- Livongo Demo Kit — LIVONGO HEALTH, INC
- Livongo Demo Kit — LIVONGO HEALTH, INC
- Livongo Lancets — LIVONGO HEALTH, INC
- Livongo Lancing Device — LIVONGO HEALTH, INC
- Livongo Refill Kit — LIVONGO HEALTH, INC
- Livongo Replacement Device — LIVONGO HEALTH, INC
- Livongo Replacement Device — LIVONGO HEALTH, INC
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
- Livongo Health, Inc
Sources (1)
- FDA UDI c97dc761-4643-4f20-bc9c-21215b91608c 37 fields · synced May 30, 2026