Identity
- Trade Name
- PLS Harness Set EUDAMEDHaemonetics® PCS®2 & NexSys PCS® Systems FDA UDI
- Generic Name
- Apheresis system tubing set FDA UDI
- Device Name
- PLS Harness Set EUDAMEDFDA UDI
- Model / Reference
- 00620-CP-CC EUDAMEDFDA UDI
- Description
- PLS HARNESS SET FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10812747019279 EUDAMEDFDA UDI
- Basic UDI-DI
- 081274701PLS0053S 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
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
PLS Harness Set 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 | 081274701PLS0053S | 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 e77d8240-d071-4724-904f-ddfd68517d26 61 fields · synced Jun 17, 2026
- FDA UDI 265999b6-c280-496b-8475-dee8713da134 35 fields · synced May 30, 2026