THERANOVA 955692
GUDID 37332414125722
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.
Gambro Dialysatoren GmbH
Hollow-fibre haemodialysis dialyser, single-use| Primary Device ID | 37332414125722 |
| NIH Device Record Key | 2d4c56bd-3165-4668-8128-da4385bdd5fc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | THERANOVA |
| Version Model Number | 500 |
| Catalog Number | 955692 |
| Company DUNS | 316150549 |
| Company Name | Gambro Dialysatoren GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
| Area/Surface Area | 2 Square meter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332414125721 [Primary] |
| GS1 | 37332414125722 [Package] Contains: 07332414125721 Package: BOX [24 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- deNovo: DEN190042
FDA Product Code
| QAX | Hemodialyzer with expanded solute removal profile |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-11-03 |
| Device Publish Date | 2020-10-26 |
On-Brand Devices [THERANOVA]
| 37332414125715 | Device w/ sterile & non-pyrogenic fluid pathways. Expanded HD, w/ Theranova, expands the range o |
| 37332414125722 | Device w/ sterile & non-pyrogenic fluid pathways. Expanded HD, w/ Theranova, expands the range o |
Trademark Results [THERANOVA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THERANOVA 90058666 not registered Live/Pending |
Theranova LLC 2020-07-17 |
 THERANOVA 87976728 5420042 Live/Registered |
Theranova LLC 2016-06-23 |
 THERANOVA 87081811 not registered Live/Pending |
Theranova LLC 2016-06-23 |
 THERANOVA 86358013 4876725 Live/Registered |
GAMBRO LUNDIA AB 2014-08-05 |
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