UDI device identifier
PRISMAFLEX TPE 2000 SET 114093
UDI device identifier 07332414111038 · GAMBRO INDUSTRIES
Key facts
| Primary DI | 07332414111038 |
|---|---|
| Brand name | PRISMAFLEX TPE 2000 SET |
| Version or model | 114093 |
| Catalog number | 114093 |
| Company | GAMBRO INDUSTRIES |
| DUNS number | 393020474 |
| Product code | MDP |
| GMDN term | Apheresis system filter, whole blood |
| Premarket submission | P830063 |
| Device class | Class III |
| Single use | Yes |
| Packaged sterile | Yes |
| Implantable | No |
| Publish date | Mar 23, 2017 |
| Version date | Aug 10, 2023 |
| 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… |
At a glance
- 1–9 MAUDE reports citing this UDI
- Yes Linked premarket submission
- No EUDAMED counterpart found
- 10–99 GUDID devices with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About UDI device identifiers (GUDID)
The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.
Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date: