Identity
- Trade Name
- Livongo Control Solution FDA UDI
- Generic Name
- Glucose IVD, control FDA UDI
- Device Name
- Livongo Control Solution with 1 bottle high / 1 bottle low FDA UDI
- Model / Reference
- Livongo FDA UDI
- Description
- Livongo Control Solution with 1 bottle high / 1 bottle low FDA UDI
Identifiers
- Catalog Number
- OFG00426 FDA UDI
- Primary DI / UDI-DI
- 00853553005202 FDA UDI
- 510(k) Number
- K133584 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Glucose IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glucose IVD, control
Livongo Control Solution by Livongo Health, Inc — Class I — 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 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
- 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 I | Pending data |
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Manufacturer
- Manufacturer
- Livongo Health, Inc
Sources (1)
- FDA UDI 882cb6b9-458d-469f-8a8a-3151d707ffe4 37 fields · synced May 31, 2026