Identity
- Trade Name
- INNOVATE MEDICAL FDA UDI
- Generic Name
- Blood culture broth kit IVD FDA UDI
- Device Name
- Blood Culture Kit FDA UDI
- Model / Reference
- 10-2000-01 FDA UDI
- Description
- Blood Culture Kit FDA UDI
Identifiers
- Catalog Number
- 10-2000-01 FDA UDI
- Primary DI / UDI-DI
- 00852937003025 FDA UDI
- FDA Product Code
- OFM FDA UDI
- GMDN Term
- Blood culture broth kit IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2750 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood culture broth kit IVD
Innovate Medical by Innovate Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- INNOVATE MEDICAL — INNOVATE MEDICAL, LLC · Class II
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
- Innovate Medical, Llc
Sources (1)
- FDA UDI 99406300-e0e4-4204-a13e-67ed5a16e91e 36 fields · synced May 30, 2026