Identity
- Trade Name
- P1R Plasma Treatment Set FDA UDI
- Generic Name
- Apheresis system tubing set FDA UDI
- Device Name
- Therapeutic Plasma Treatment (e.g. LDL-apheresis) FDA UDI
- Model / Reference
- 9400414 FDA UDI
- Description
- Therapeutic Plasma Treatment (e.g. LDL-apheresis) FDA UDI
Identifiers
- Catalog Number
- 9400414 FDA UDI
- Primary DI / UDI-DI
- 04052682003721 FDA UDI
- 510(k) Number
- K961706 FDA UDI
- FDA Product Code
- LKN FDA UDI
- GMDN Term
- Apheresis system tubing set FDA UDI
Classification
- Device Class
- U 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: Apheresis system tubing set
P1R Plasma Treatment Set by Fresenius Kabi — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 U | Pending data |
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Manufacturer
- Manufacturer
- Fresenius Kabi
Sources (1)
- FDA UDI 1c085a0e-f1fe-4721-b0d4-8223ecfbc3de 37 fields · synced May 30, 2026