Identity
- Trade Name
- HAEMONETICS SMARTSUCTION HARMONY SYSTEM FDA UDI
- Generic Name
- Autotransfusion system blood component processing set FDA UDI
- Device Name
- VACUUM LINE, UNFILTERED FDA UDI
- Model / Reference
- HAR-A-1001 FDA UDI
- Description
- VACUUM LINE, UNFILTERED FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10812747017343 FDA UDI
- 510(k) Number
- K052626 FDA UDI
- FDA Product Code
- BTA FDA UDI
- GMDN Term
- Autotransfusion system blood component processing set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Over-the-Counter
No
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
Haemonetics Smartsuction Harmony System by Haemonetics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- Haemonetics Corporation
Sources (1)
- FDA UDI 15032163-c571-49dc-82a1-a10fe3c91a7a 36 fields · synced Jun 8, 2026