Identity
- Trade Name
- Cardioplegia Plus FDA UDI
- Generic Name
- Blood donor set, single-pack FDA UDI
- Device Name
- Filters with Solution Spike FDA UDI
- Model / Reference
- CPS02 FDA UDI
- Description
- Filters with Solution Spike FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10887691000307 FDA UDI
- 510(k) Number
- K875095 FDA UDI
- FDA Product Code
- JOD FDA UDI
- GMDN Term
- Blood donor set, single-pack FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4270 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
Category: Blood donor set, single-pack
Cardioplegia Plus by Haemonetics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Fresh Whole Blood Donor Transfusion Set — SAFEGUARD US OPERATING, LLC · Class II
- Fresh Whole Blood Transfusion Set — SAFEGUARD US OPERATING, LLC · Class II
- Fresh Whole Blood Donor Transfusion Set — SAFEGUARD US OPERATING, 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
- Haemonetics Corporation
Sources (1)
- FDA UDI 5fcd5b7e-6fff-47d9-a7cf-c9b0c67f74ba 35 fields · synced Jun 8, 2026