| Primary Device ID | 37332414126958 |
| NIH Device Record Key | 1ca0fb18-4b8b-491a-a0e2-604f19b9fb6d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | U9000 Plus ultrafilter |
| Version Model Number | 955825 |
| Catalog Number | 955825 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Phone | +1(800)933-0303 |
| medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| medinfo_medproducts@baxter.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332414126957 [Primary] |
| GS1 | 37332414126958 [Package] Contains: 07332414126957 Package: CASE [16 Units] In Commercial Distribution |
| FIP | Subsystem, water purification |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-01-07 |
| Device Publish Date | 2021-12-30 |
| 37332414126958 - U9000 Plus ultrafilter | 2022-01-07The U9000 Plus Ultrafilter is indicated for purification of incoming water for dialysis fluid as well as purification of dialysis fluid to obtain microbiological high quality dialysis fluid. The risk of exposure to bacteria and endotoxins can thereby be minimized. |
| 37332414126958 - U9000 Plus ultrafilter | 2022-01-07 The U9000 Plus Ultrafilter is indicated for purification of incoming water for dialysis fluid as well as purification of dialysi |
| 37332414126194 - REVACLEAR | 2021-11-16 Revaclear 300 dialyzers are indicated for treatment of chronic and acute renal failure by Hemodialysis. |
| 37332414126200 - REVACLEAR | 2021-11-16 Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by Hemodialysis. |
| 37332414102501 - Ultrafilter U 9000 | 2021-04-08 The U9000 Ultrafilter is indicated for purification of incoming water for dialysis fluid as well as purification of dialysis flu |
| 37332414125722 - THERANOVA | 2020-11-03 Device w/ sterile & non-pyrogenic fluid pathways. Expanded HD, w/ Theranova, expands the range of molecules efficiently removed |
| 37332414125715 - THERANOVA | 2020-09-10 Device w/ sterile & non-pyrogenic fluid pathways. Expanded HD, w/ Theranova, expands the range of molecules efficiently removed |
| 37332414015481 - Adsorba Hemoperfusion cartridge | 2018-07-06 The Adsorba 150C hemoperfusion cartridge is a steam sterilized device which contains 150 grams of cellulose-coated activated cha |
| 37332414031771 - Polyflux | 2018-07-06 Polyflux R is intended for use in hemodialysis for the treatment of chronic and acute renal failure Polyflux R may be reprocesse |