Identity
- Trade Name
- PRISMAFLEX TPE 2000 SET FDA UDI
- Generic Name
- Apheresis system filter, whole blood FDA UDI
- Device Name
- The Prismaflex TPE2000 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered), after having selected TPE therapy. The Prismaflex TPE2000 set is intended for use in therapeutic plasma exchange, thus in diseases where removal of plasma components in indicated. FDA UDI
- Model / Reference
- 114093 FDA UDI
- Description
- The Prismaflex TPE2000 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered), after having selected TPE therapy. The Prismaflex TPE2000 set is intended for use in therapeutic plasma exchange, thus in diseases where removal of plasma components in indicated. FDA UDI
Identifiers
- Catalog Number
- 114093 FDA UDI
- Primary DI / UDI-DI
- 07332414111038 FDA UDI
- PMA Number
- P830063 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
Yes
FDA UDI
Category: Apheresis system filter, whole blood
Prismaflex Tpe 2000 Set by Gambro Industries — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Apheresis system filter, whole blood.
- Plasmaflo — ASAHIKASEI MEDICAL MT K.K. · Class III
- SULFLUX — Kaneka Pharma America Corp. · Unclassified
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
- Gambro Industries
Sources (1)
- FDA UDI 214a1eb8-bc63-46c4-b586-c4d704367679 37 fields · synced May 30, 2026