U9000 Plus ultrafilter 955825

GUDID 37332414126958

The 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.

Gambro Dialysatoren GmbH

Microbial water purification filter, sterilizable

• 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

Customer Support Contacts

• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332414126957 [Primary]
GS1	37332414126958 [Package]; Contains: 07332414126957; Package: CASE [16 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211035

FDA Product Code

• FIP: Subsystem, water purification

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-07
• Device Publish Date: 2021-12-30

Devices Manufactured by Gambro Dialysatoren GmbH

• 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