AccessGUDID - DEVICE: Homechoice Claria (00085412676463)

GUDID

Device Identifier (DI) Information

Brand Name: Homechoice Claria
Version or Model: 5C6M40
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5C6M40
Company Name: BAXTER HEALTHCARE CORPORATION

Primary DI Number: 00085412676463
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005083209 *Terms of Use

Device Description: Homechoice Claria Automated Peritoneal Dialysis Cycler

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
11226	Peritoneal dialysis system	An assembly of devices consisting of functional units [e.g., a mains electricity (AC-powered) pump, solution mixer, monitor] intended to perform peritoneal dialysis, a treatment that removes fluid and metabolic wastes from the blood by infusing dialysate into the peritoneal cavity through a catheter and a disposable tubing system, and then removing the dialysate. Diffusion of metabolic wastes from the blood to the dialysate occurs within the abdominal cavity through the pores and intercellular channels of the peritoneum. The device may automatically control the flow of dialysate into and out of the abdominal cavity.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FKX	System, peritoneal, automatic delivery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K201867	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
Storage Environment Humidity: between 10 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between -32 and 54 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 01893c09-cf88-4abc-82dd-e44e065ebea9
Public Version Date: July 19, 2023
Public Version Number: 3
DI Record Publish Date: December 01, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
50085412676468	1	00085412676463		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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES