Identity
- Trade Name
- FIA Salut CS06 FDA UDI
- Generic Name
- Glucose IVD, kit, electrometry FDA UDI
- Device Name
- FIA Salut CS06 Blood Glucose Monitoring System. FDA UDI
- Model / Reference
- 3K-01-1400316 FDA UDI
- Description
- FIA Salut CS06 Blood Glucose Monitoring System. FDA UDI
Identifiers
- Catalog Number
- 3K-01-1400316 FDA UDI
- Primary DI / UDI-DI
- 04260236850244 FDA UDI
- 510(k) Number
- K121433 FDA UDI
- FDA Product Code
- LFR FDA UDINBW FDA UDI
- GMDN Term
- Glucose IVD, kit, electrometry 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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Glucose IVD, kit, electrometryGlucose monitoring system IVD, point-of-care
FIA Salut CS06 by Hmd Biomedical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K121433 also covers:
- FIA Salut foil packed test strip — Hmd Biomedical, LLC
- FIA Salut foil packed test strip(for SS) — Hmd Biomedical, LLC
- FIA Salut vial packed test strip — Hmd Biomedical, LLC
- FIA Salut vial packed test strip — Hmd Biomedical, LLC
- FIA Salut vial packed test strip — Hmd Biomedical, LLC
- FIA Salut vial packed test strip(for Elhenawy) — Hmd Biomedical, LLC
- FIA Salut vial packed test strip(for SS) — Hmd Biomedical, LLC
- FIA Salut vial packed test strip(for SS) — Hmd Biomedical, LLC
- Renpho Blood Glucose Monitoring System — Hmd Biomedical, LLC
- Renpho Blood Glucose vial packed test strip — Hmd Biomedical, LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hmd Biomedical, LLC
Sources (1)
- FDA UDI d5bc60d6-6d7a-430b-a7ef-f68086341135 36 fields · synced Jun 6, 2026