Identity
- Trade Name
- Plasmaflo FDA UDI
- Generic Name
- Apheresis system filter, whole blood FDA UDI
- Device Name
- The Plasmaflo OP-05W(A) Asahi plasma separator is a medical device intended for the therapeutic separation of plasma from the whole blood in a clinical setting. FDA UDI
- Model / Reference
- OP-05W(A) FDA UDI
- Description
- The Plasmaflo OP-05W(A) Asahi plasma separator is a medical device intended for the therapeutic separation of plasma from the whole blood in a clinical setting. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04537693005365 FDA UDI
- FDA Product Code
- MDP FDA UDI
- GMDN Term
- Apheresis system filter, whole blood FDA UDI
Classification
- Device Class
- Class III 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
No
FDA UDI
Category: Apheresis system filter, whole blood
Plasmaflo by Asahikasei Medical Mt K.k. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Apheresis system filter, whole blood.
- SULFLUX — Kaneka Pharma America Corp. · Unclassified
- PRISMAFLEX TPE 2000 SET — GAMBRO INDUSTRIES · Class III
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 III | Pending data |
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Manufacturer
- Manufacturer
- Asahikasei Medical Mt K.k.
Sources (1)
- FDA UDI 5ee01d68-f06a-4ee5-b02a-554d50793406 35 fields · synced May 30, 2026