Identity
- Trade Name
- 0625Q-00 Plasma Bowl EUDAMEDHaemonetics® NexSys PCS® System FDA UDI
- Generic Name
- Apheresis system tubing set FDA UDI
- Device Name
- Plasma Bowl EUDAMED0625Q-00 Plasma Bowl FDA UDI
- Model / Reference
- 0625Q-00 EUDAMEDFDA UDI
- Description
- 0625Q-00 Plasma Bowl FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10812747019736 EUDAMEDFDA UDI
- Basic UDI-DI
- 081274701PLS0023L EUDAMED
- FDA Product Code
- GKT FDA UDI
- EMDN Code
- B030101 APHERESIS PLASMA COLLECTION DEVICES EUDAMED
- GMDN Term
- Apheresis system tubing set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 864.9245 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
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
0625Q-00 Plasma Bowl by Haemonetics Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081274701PLS0023L | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Haemonetics Corporation
- EUDAMED SRN
- US-MF-000034539
- Authorised Representative
- Haemonetics Italia s.r.l IT-AR-000021067
Sources (2)
- EUDAMED 3d47ff88-c9a7-438d-9a45-eb6c2801a359 61 fields · synced Jun 19, 2026
- FDA UDI 5dd2ace8-37ed-4459-b7e0-273d833ac1ea 35 fields · synced May 24, 2026