Identity
- Trade Name
- Platelet Wash and Storage Solution EUDAMEDFDA UDI
- Generic Name
- Platelet storage solution FDA UDI
- Device Name
- Platelet Wash and Storage Solution EUDAMEDPlatelet Wash and Storage Solution (PWSS) is used to wash, suspend and store platelets. The solution is provided in a 1 liter bag. FDA UDI
- Model / Reference
- 0005035 EUDAMEDFDA UDI
- Description
- Platelet Wash and Storage Solution (PWSS) is used to wash, suspend and store platelets. The solution is provided in a 1 liter bag. FDA UDI
Identifiers
- Catalog Number
- 0005035 FDA UDI
- Primary DI / UDI-DI
- 10888234000488 EUDAMEDFDA UDI
- Basic UDI-DI
- 88823401W01030399A0000249 EUDAMED
- FDA Product Code
- KSS FDA UDI
- EMDN Code
- W0103010605 PLATELETS EUDAMED
- GMDN Term
- Platelet storage solution FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.9050 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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
Platelet Wash and Storage Solution by Immucor, Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 88823401W01030399A0000249 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Immucor, Inc.
- EUDAMED SRN
- US-MF-000011568
- Authorised Representative
- IMMUCOR Medizinische Diagnostik GmbH DE-AR-000007083
Sources (2)
- EUDAMED df1bfdc8-2a30-4f7f-8ca8-4f5eebbdce74 61 fields · synced Jun 19, 2026
- FDA UDI 18845d09-6007-4991-8b81-779a6516a34b 37 fields · synced May 30, 2026