Identity
- Trade Name
- PSQ Set FDA UDI
- Generic Name
- Autotransfusion system blood component processing set FDA UDI
- Device Name
- PSQ Set comprises: 1. a storage bag for PRP and plasma including connection lines for the reinfusion bag of the AT1 Autotransfusion Set (=PRC bag) and for the waste line 2. an adapter for connecting the standard blood bag to the blood inlet line of the AT1 Autotransfusion Set 3. a separate reservoir connection line. FDA UDI
- Model / Reference
- 9005144 FDA UDI
- Description
- PSQ Set comprises: 1. a storage bag for PRP and plasma including connection lines for the reinfusion bag of the AT1 Autotransfusion Set (=PRC bag) and for the waste line 2. an adapter for connecting the standard blood bag to the blood inlet line of the AT1 Autotransfusion Set 3. a separate reservoir connection line. FDA UDI
Identifiers
- Catalog Number
- 9005144 FDA UDI
- Primary DI / UDI-DI
- 04052682000461 FDA UDI
- FDA Product Code
- CAC FDA UDI
- GMDN Term
- Autotransfusion system blood component processing set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5830 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
Category: Autotransfusion system blood component processing set
PSQ Set by Fresenius Kabi — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- HAEMONETICS PCS 2 APHERESIS SYSTEM — HAEMONETICS CORPORATION · 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
- Fresenius Kabi
Sources (1)
- FDA UDI 3623b915-077d-40d1-b384-2847c63caf4a 36 fields · synced Jun 1, 2026