CLCA - CLEANCART A 955850

GUDID 37332414127214

CleanCart A

GAMBRO AB

Sodium carbonate haemodialysis system cleaning cartridge
Primary Device ID37332414127214
NIH Device Record Key6b850034-1213-4c51-96eb-b1945b11a391
Commercial Distribution StatusIn Commercial Distribution
Brand NameCLCA - CLEANCART A
Version Model Number955850
Catalog Number955850
Company DUNS354021099
Company NameGAMBRO AB
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 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
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
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 Dimensions

Weight13 Gram
Weight13 Gram
Weight13 Gram
Weight13 Gram
Weight13 Gram
Weight13 Gram
Weight13 Gram
Weight13 Gram
Weight13 Gram
Weight13 Gram
Weight13 Gram
Weight13 Gram
Weight13 Gram
Weight13 Gram
Weight13 Gram
Weight13 Gram
Weight13 Gram
Weight13 Gram
Weight13 Gram
Weight13 Gram
Weight13 Gram
Weight13 Gram
Weight13 Gram
Weight13 Gram
Weight13 Gram
Weight13 Gram
Weight13 Gram
Weight13 Gram
Weight13 Gram
Weight13 Gram

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Do not store above 30°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Do not store above 30°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Do not store above 30°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Do not store above 30°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Do not store above 30°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Do not store above 30°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Do not store above 30°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Do not store above 30°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Do not store above 30°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Do not store above 30°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Do not store above 30°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Do not store above 30°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Do not store above 30°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Do not store above 30°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Do not store above 30°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Do not store above 30°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Do not store above 30°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Do not store above 30°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Do not store above 30°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Do not store above 30°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Do not store above 30°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Do not store above 30°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Do not store above 30°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Do not store above 30°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Do not store above 30°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Do not store above 30°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Do not store above 30°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Do not store above 30°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Do not store above 30°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Do not store above 30°C.

Device Identifiers

Device Issuing AgencyDevice ID
GS107332414127213 [Primary]
GS137332414127214 [Package]
Contains: 07332414127213
Package: [33 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KDIDialyzer, high permeability with or without sealed dialysate system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-11
Device Publish Date2023-12-01

Devices Manufactured by GAMBRO AB

37332414127214 - CLCA - CLEANCART A2023-12-11CleanCart A
37332414127214 - CLCA - CLEANCART A2023-12-11 CleanCart A
37332414127221 - CLCC - CLEANCART C2023-12-11 CleanCart C
07332414124519 - AK 982021-03-30 Intended for intermittant haemodialysis and/or isolated ultrafiltration treatments. Indicated to be used on patients with a body
07332414126766 - PRISMAFLEX2019-03-11 The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy an
37332414107728 - MARS TREATMENT KIT TYPE 1116/1 - X-MARS US2019-02-13 The MARS Treatment Kit Type 1116/1 X-MARS is a set of disposable items to be used with the MARS Monitor 1TC in combination with
37332414106950 - Mars Treatment Kit2018-07-06 The MARS Treatment Kit type 1115/1-PrisMARS US is a set of disposable items to be used with the MARS Monitor 1TC for performing
37332414088317 - BiCart2018-07-06 Sodium Bicarbonate for Hemodialysis
07332414105266 - Prismaflex2018-07-06 The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy an

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