CLCC - CLEANCART C 955851

GUDID 37332414127221

CleanCart C

GAMBRO AB

Citric acid haemodialysis system cleaning cartridge

Primary Device ID	37332414127221
NIH Device Record Key	5217c73a-1633-4d1e-9fd1-c35ea5c18166
Commercial Distribution Status	In Commercial Distribution
Brand Name	CLCC - CLEANCART C
Version Model Number	955851
Catalog Number	955851
Company DUNS	354021099
Company Name	GAMBRO AB
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	true
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
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)553-6898
Email	Us.RENAL.Support.Co@vantive.com
Phone	+1(800)553-6898
Email	Us.RENAL.Support.Co@vantive.com
Phone	+1(800)553-6898
Email	Us.RENAL.Support.Co@vantive.com
Phone	+1(800)553-6898
Email	Us.RENAL.Support.Co@vantive.com
Phone	+1(800)553-6898
Email	Us.RENAL.Support.Co@vantive.com
Phone	+1(800)553-6898
Email	Us.RENAL.Support.Co@vantive.com
Phone	+1(800)553-6898
Email	Us.RENAL.Support.Co@vantive.com
Phone	+1(800)553-6898
Email	Us.RENAL.Support.Co@vantive.com
Phone	+1(800)553-6898
Email	Us.RENAL.Support.Co@vantive.com
Phone	+1(800)553-6898
Email	Us.RENAL.Support.Co@vantive.com
Phone	+1(800)553-6898
Email	Us.RENAL.Support.Co@vantive.com
Phone	+1(800)553-6898
Email	Us.RENAL.Support.Co@vantive.com
Phone	+1(800)553-6898
Email	Us.RENAL.Support.Co@vantive.com

Device Dimensions

Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram
Weight	32 Gram

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332414127220 [Primary]
GS1	37332414127221 [Package] Contains: 07332414127220 Package: [33 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K232467

FDA Product Code

KDI	Dialyzer, high permeability with or without sealed dialysate system

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	2023-12-11
Device Publish Date	2023-12-01

Devices Manufactured by GAMBRO AB

37332414127214 - CLCA - CLEANCART A	2023-12-11 CleanCart A
37332414127221 - CLCC - CLEANCART C	2023-12-11CleanCart C
37332414127221 - CLCC - CLEANCART C	2023-12-11 CleanCart C
07332414124519 - AK 98	2021-03-30 Intended for intermittant haemodialysis and/or isolated ultrafiltration treatments. Indicated to be used on patients with a body
07332414126766 - PRISMAFLEX	2019-03-11 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 US	2019-02-13 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 Kit	2018-07-06 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 - BiCart	2018-07-06 Sodium Bicarbonate for Hemodialysis
07332414105266 - Prismaflex	2018-07-06 The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy an