Identity
- Trade Name
- HARVEST® BMAC® 2 FDA UDI
- Generic Name
- Haematological concentrate system preparation kit, bone marrow concentration FDA UDI
- Device Name
- Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-30-01 Procedure Pack FDA UDI
- Model / Reference
- 51420 FDA UDI
- Description
- Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-30-01 Procedure Pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05020583514201 FDA UDI
- FDA Product Code
- FMF FDA UDIJQC FDA UDI
- GMDN Term
- Haematological concentrate system preparation kit, bone marrow concentration FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 FDA UDI862.2050 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Harvest® Bmac® 2 by Terumo BCT, Inc.. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Terumo BCT, Inc..
Sources (1)
- FDA UDI 815ece48-1c2f-48c2-a911-1c486a55ebe6 36 fields · synced Jun 6, 2026