DEVICE: AMIA Automated PD Cycler (00085412490120)

Device Identifier (DI) Information

AMIA Automated PD Cycler
5C9320
In Commercial Distribution
5C9320
BAXTER INTERNATIONAL INC.
00085412490120
GS1

1
005146311 *Terms of Use
Amia Automated PD System is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

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Product Code Product Code Name
FKX SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K151525 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
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 Temperature: between -32 and 54 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

2d15140f-622b-4cd0-a3ee-d361e45b4f78
July 06, 2018
3
November 04, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
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Customer Contact

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