AccessGUDID - DEVICE: HomeChoice PRO APD System (00085412079165)

GUDID

Device Identifier (DI) Information

Brand Name: HomeChoice PRO APD System
Version or Model: 5C8310
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5C8310
Company Name: BAXTER INTERNATIONAL INC.

Primary DI Number: 00085412079165
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005146311 *Terms of Use

Device Description: The HomeChoice PRO Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.

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:	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?
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 [?]
K102936	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: Stacking limit; do not stack more than 5 high
Special Storage Condition, Specify: Altitude -1,100 ft to +18,000 ft (-340 m to +5,500m)
Special Storage Condition, Specify: Keep dry
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -25 and 130 Degrees Fahrenheit
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between -25 and 130 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ec3d0cf8-9578-4912-8fca-87b3b356e101
Public Version Date: July 21, 2023
Public Version Number: 5
DI Record Publish Date: October 23, 2015