Identity
- Trade Name
- HAEMONETICS CELL SAVER SYSTEM FDA UDI
- Generic Name
- Autotransfusion system blood component processing set FDA UDI
- Device Name
- RESERVOIR, HARD-SHELL, 20µ_ Additional packaging DI: 20812747016060, Unit packaging, contains (1) 1082747016063 FDA UDI
- Model / Reference
- 00220-00 FDA UDI
- Description
- RESERVOIR, HARD-SHELL, 20µ_ Additional packaging DI: 20812747016060, Unit packaging, contains (1) 1082747016063 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10812747016063 FDA UDI
- 510(k) Number
- K932890 FDA UDI
- FDA Product Code
- CAC FDA UDI
- GMDN Term
- Autotransfusion system blood component processing set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5830 FDA UDI
- Commercial Distribution
- 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
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
Dimensions & Sizes
- Size
- Pore Size — 20 Micrometer FDA UDI
Category: Autotransfusion system blood component processing set
Haemonetics Cell Saver System by Haemonetics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K932890 also covers:
- HAEMONETICS CELL SAVER 5+ SYSTEM — HAEMONETICS CORPORATION
- HAEMONETICS CELL SAVER 5/5+ SYSTEM — HAEMONETICS CORPORATION
- HAEMONETICS CELL SAVER 5/5+ SYSTEMS — HAEMONETICS CORPORATION
- HAEMONETICS CELL SAVER 5/5+ SYSTEMS — HAEMONETICS CORPORATION
- HAEMONETICS CELL SAVER 5/5+ SYSTEMS — HAEMONETICS CORPORATION
- HAEMONETICS CELL SAVER 5/5+ SYSTEMS — HAEMONETICS CORPORATION
- HAEMONETICS CELL SAVER 5/5+ SYSTEMS — HAEMONETICS CORPORATION
- HAEMONETICS CELL SAVER 5/5+ SYSTEMS — HAEMONETICS CORPORATION
- HAEMONETICS CELL SAVER SYSTEM — HAEMONETICS CORPORATION
- HAEMONETICS CELL SAVER SYSTEM — HAEMONETICS CORPORATION
- HAEMONETICS CELL SAVER SYSTEM — HAEMONETICS CORPORATION
- HAEMONETICS CELL SAVER SYSTEM — HAEMONETICS CORPORATION
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 7771d752-8568-4480-96f8-1c92c44d6eab 36 fields · synced Jun 6, 2026