AccessGUDID - DEVICE: CLCA - CLEANCART A (07332414127213)

GUDID

Device Identifier (DI) Information

Brand Name: CLCA - CLEANCART A
Version or Model: 955850
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 955850
Company Name: GAMBRO AB

Primary DI Number: 07332414127213
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 354021099 *Terms of Use

Device Description: CleanCart A

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58905	Sodium carbonate haemodialysis system cleaning cartridge	A non-sterile cartridge containing anhydrous sodium carbonate designed to be connected to the fluid circuit of an institutional haemodialysis system for the in-line preparation of a sodium carbonate solution to clean the fluid pathways of the system (remove organic deposits, fats, proteins) in combination with a heat disinfection program. The solution is typically rinsed or flushed in a closed loop for a specified period. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDI	Dialyzer, high permeability with or without sealed dialysate system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K232467	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep Dry. Do not store above 30°C.

Clinically Relevant Size

[?]

Size Type Text
Weight: 13 Gram

Device Record Status

Public Device Record Key: 6b850034-1213-4c51-96eb-b1945b11a391
Public Version Date: January 22, 2024
Public Version Number: 2
DI Record Publish Date: December 01, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
37332414127214	33	07332414127213		In Commercial Distribution	Case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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