AMIA Automated PD Cycler 5C9320

GUDID 00085412490120

Amia Automated PD System is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis

BAXTER INTERNATIONAL INC.

Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system

• Primary Device ID: 00085412490120
• NIH Device Record Key: 2d15140f-622b-4cd0-a3ee-d361e45b4f78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMIA Automated PD Cycler
• Version Model Number: 5C9320
• Catalog Number: 5C9320
• Company DUNS: 005146311
• Company Name: BAXTER INTERNATIONAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Operating and Storage Conditions

• Storage Environment Temperature: Between -32 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -32 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -32 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -32 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -32 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -32 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -32 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Transportation Atmospheric Pressure Range: 7.3 psia to 15.3 psia
• Storage Environment Temperature: Between -25.6 Degrees Fahrenheit and 129.2 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Noncondensing humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -32 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Transportation Atmospheric Pressure Range: 7.3 psia to 15.3 psia
• Storage Environment Temperature: Between -25.6 Degrees Fahrenheit and 129.2 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Noncondensing humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -32 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Transportation Atmospheric Pressure Range: 7.3 psia to 15.3 psia
• Storage Environment Temperature: Between -25.6 Degrees Fahrenheit and 129.2 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Noncondensing humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -32 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Transportation Atmospheric Pressure Range: 7.3 psia to 15.3 psia
• Storage Environment Temperature: Between -25.6 Degrees Fahrenheit and 129.2 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Noncondensing humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -32 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Transportation Atmospheric Pressure Range: 7.3 psia to 15.3 psia
• Storage Environment Temperature: Between -25.6 Degrees Fahrenheit and 129.2 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Noncondensing humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -32 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Transportation Atmospheric Pressure Range: 7.3 psia to 15.3 psia
• Storage Environment Temperature: Between -25.6 Degrees Fahrenheit and 129.2 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Noncondensing humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -32 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Transportation Atmospheric Pressure Range: 7.3 psia to 15.3 psia
• Storage Environment Temperature: Between -25.6 Degrees Fahrenheit and 129.2 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Noncondensing humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -32 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Transportation Atmospheric Pressure Range: 7.3 psia to 15.3 psia
• Storage Environment Temperature: Between -25.6 Degrees Fahrenheit and 129.2 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Noncondensing humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -32 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Transportation Atmospheric Pressure Range: 7.3 psia to 15.3 psia
• Storage Environment Temperature: Between -25.6 Degrees Fahrenheit and 129.2 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Noncondensing humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -32 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Transportation Atmospheric Pressure Range: 7.3 psia to 15.3 psia
• Storage Environment Temperature: Between -25.6 Degrees Fahrenheit and 129.2 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Noncondensing humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085412490120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151525

FDA Product Code

• FKX: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-11-04

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