Identity
- Trade Name
- THERANOVA FDA UDI
- Generic Name
- Hollow-fibre haemodialysis dialyser, single-use FDA UDI
- Device Name
- Device w/ sterile & non-pyrogenic fluid pathways. Expanded HD, w/ Theranova, expands the range of molecules efficiently removed during intermittent HD. Dialyzers provide increased removal of various conventional middle (500 Da - <25 kDa) & large middle (25 - 45 kDa) molecules compared to HF membranes. Performances are achieved using existing HD workflow and infrastructure. FDA UDI
- Model / Reference
- 500 FDA UDI
- Description
- Device w/ sterile & non-pyrogenic fluid pathways. Expanded HD, w/ Theranova, expands the range of molecules efficiently removed during intermittent HD. Dialyzers provide increased removal of various conventional middle (500 Da - <25 kDa) & large middle (25 - 45 kDa) molecules compared to HF membranes. Performances are achieved using existing HD workflow and infrastructure. FDA UDI
Identifiers
- Catalog Number
- 955692 FDA UDI
- Primary DI / UDI-DI
- 07332414125721 FDA UDI
- 510(k) Number
- DEN190042 FDA UDI
- FDA Product Code
- QAX FDA UDI
- GMDN Term
- Hollow-fibre haemodialysis dialyser, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5862 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
Dimensions & Sizes
- Size
- Area/Surface Area — 2.0 Square meter FDA UDI
Category: Hollow-fibre haemodialysis dialyser, single-use
Theranova by Gambro Dialysatoren GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hollow-fibre haemodialysis dialyser, single-use.
- REVACLEAR — Gambro Renal Products, Inc. · Class II
- NIPRO ELISIO™ -H HEMODIALYZER — NIPRO MEDICAL CORPORATION · Class II
- xevonta — B.Braun Avitum AG · Class II
- Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II
- NIPRO ELISIO™ -M HEMODIALYZER — NIPRO MEDICAL CORPORATION · Class II
- FX CorAL 60 Dialyzer — Fresenius Medical Care Holdings, Inc. · Class II
- Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II
- Optiflux® — Fresenius Medical Care Holdings, Inc. · Class II
Cleared under the same submission
DEN190042 also covers:
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
- Gambro Dialysatoren GmbH
Sources (1)
- FDA UDI 2d4c56bd-3165-4668-8128-da4385bdd5fc 38 fields · synced Jun 8, 2026