Identity
- Trade Name
- HAEMONETICS ACP 215 SYSTEM FDA UDI
- Generic Name
- Blood cell freeze/thaw system set FDA UDI
- Device Name
- RBC DE-GLYCEROL. SET 325ML BMB FDA UDI
- Model / Reference
- 00236-00 FDA UDI
- Description
- RBC DE-GLYCEROL. SET 325ML BMB FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10812747015028 FDA UDI
- FDA Product Code
- KSW FDA UDI
- GMDN Term
- Blood cell freeze/thaw system set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9145 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 5 Liter FDA UDITotal Volume — 325 Milliliter FDA UDITotal Volume — 600 Milliliter FDA UDI
Category: Blood cell freeze/thaw system set
Haemonetics Acp 215 System by Haemonetics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood cell freeze/thaw system set.
- HAEMONETICS ACP 215 SYSTEM — HAEMONETICS CORPORATION · Class II
- HAEMONETICS ACP 215 SYSTEM — HAEMONETICS CORPORATION · Class II
Cleared under the same submission
BK030062 also covers:
BK040077 also covers:
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 cc724c0e-ea97-4aee-b638-a9fcd778668f 36 fields · synced Jun 6, 2026