AccessGUDID - DEVICE: AMIA Automated PD Cycler (00085412490120)

GUDID

Device Identifier (DI) Information

Brand Name: AMIA Automated PD Cycler
Version or Model: 5C9320
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5C9320
Company Name: BAXTER INTERNATIONAL INC.

Primary DI Number: 00085412490120
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005146311 *Terms of Use

Device Description: Amia Automated PD System is intended for automatic control of dialysate solution exchanges in the treatment of 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 [?]
K151525	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: Storage and Transportation Atmospheric Pressure Range: 7.3 psia to 15.3 psia
Storage Environment Temperature: between -25.6 and 129.2 Degrees Fahrenheit
Special Storage Condition, Specify: Noncondensing humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -32 and 54 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2d15140f-622b-4cd0-a3ee-d361e45b4f78
Public Version Date: July 21, 2023
Public Version Number: 5
DI Record Publish Date: November 04, 2015