Dual Lumen Extended Length Catheter 114153

GUDID 27332414112367

The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic thera

GAMBRO UF SOLUTIONS, INC

Double-lumen haemodialysis catheter, nonimplantable
Primary Device ID27332414112367
NIH Device Record Key548452fa-6bd8-4210-b092-2d082e87f544
Commercial Distribution Discontinuation2017-07-14
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDual Lumen Extended Length Catheter
Version Model Number114153
Catalog Number114153
Company DUNS132629788
Company NameGAMBRO UF SOLUTIONS, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107332414112363 [Primary]
GS127332414112367 [Package]
Contains: 07332414112363
Package: BOX [5 Units]
Discontinued: 2017-07-14
Not in Commercial Distribution
GS157332414112368 [Package]
Package: CASE [50 Units]
Discontinued: 2017-07-14
Not in Commercial Distribution

FDA Product Code

KDIDialyzer, high permeability with or without sealed dialysate system

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-10-12

Devices Manufactured by GAMBRO UF SOLUTIONS, INC

57332414112269 - NA2018-10-29 A6001 5L Effluent Bag
07332414112301 - Aquadex FlexFlow2018-03-29 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have
27332414112367 - Dual Lumen Extended Length Catheter2018-03-29The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic thera
27332414112367 - Dual Lumen Extended Length Catheter2018-03-29 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have
37332414112371 - Blood Circuit Set2018-03-29 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have
37332414112388 - Blood Circuit Set2018-03-29 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have
37332414119325 - Dual Lumen Extended Length Catheter and GALT inser2018-03-29 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have

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