Ultrafilter U 9000 112062

GUDID 37332414102501

The U9000 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 Microbial water purification filter, sterilizable Microbial water purification filter, sterilizable Microbial water purification filter, sterilizable Microbial water purification filter, sterilizable Microbial water purification filter, sterilizable Microbial water purification filter, sterilizable Microbial water purification filter, sterilizable Microbial water purification filter, sterilizable Microbial water purification filter, sterilizable Microbial water purification filter, sterilizable Microbial water purification filter, sterilizable Microbial water purification filter, sterilizable Microbial water purification filter, sterilizable Microbial water purification filter, sterilizable Microbial water purification filter, sterilizable
Primary Device ID37332414102501
NIH Device Record Keye268d25d-83a0-447c-b233-852357b84842
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltrafilter U 9000
Version Model Number112062
Catalog Number112062
Company DUNS316150549
Company NameGambro Dialysatoren GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107332414102500 [Primary]
GS137332414102501 [Package]
Contains: 07332414102500
Package: CASE [16 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FIPSubsystem, water purification

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-08
Device Publish Date2021-03-31

Devices Manufactured by Gambro Dialysatoren GmbH

37332414102501 - Ultrafilter U 90002021-04-08The U9000 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.
37332414102501 - Ultrafilter U 90002021-04-08 The U9000 Ultrafilter is indicated for purification of incoming water for dialysis fluid as well as purification of dialysis flu
37332414125722 - THERANOVA2020-11-03 Device w/ sterile & non-pyrogenic fluid pathways. Expanded HD, w/ Theranova, expands the range of molecules efficiently removed
37332414125715 - THERANOVA2020-09-10 Device w/ sterile & non-pyrogenic fluid pathways. Expanded HD, w/ Theranova, expands the range of molecules efficiently removed
37332414015481 - Adsorba Hemoperfusion cartridge2018-07-06 The Adsorba 150C hemoperfusion cartridge is a steam sterilized device which contains 150 grams of cellulose-coated activated cha
37332414031771 - Polyflux2018-07-06 Polyflux R is intended for use in hemodialysis for the treatment of chronic and acute renal failure Polyflux R may be reprocesse
37332414031788 - Polyflux2018-07-06 Polyflux R is intended for use in hemodialysis for the treatment of chronic and acute renal failure Polyflux R may be reprocesse
37332414036141 - Polyflux2018-07-06 Polyflux R is intended for use in hemodialysis for the treatment of chronic and acute renal failure Polyflux R may be reprocesse
37332414036387 - Polyflux2018-07-06 the Polyflux 6H is intended for chronic and acute applications in haemodialysis haemofiltration and hemofiltration on small pati

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