HomeChoice APD System 5C4471

GUDID 00085412007021

The HomeChoice 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.

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: 00085412007021
• NIH Device Record Key: 26237d7e-6fc7-4bf4-9737-c9732b5b7e6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HomeChoice APD System
• Version Model Number: 5C4471
• Catalog Number: 5C4471
• 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

• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Altitude -1,100 ft to +18,000 ft (-340 m to +5,500m), Keep Dry, Do not stack more than 5 high
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Altitude -1,100 ft to +18,000 ft (-340 m to +5,500m), Keep Dry, Do not stack more than 5 high
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Altitude -1,100 ft to +18,000 ft (-340 m to +5,500m), Keep Dry, Do not stack more than 5 high
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Altitude -1,100 ft to +18,000 ft (-340 m to +5,500m), Keep Dry, Do not stack more than 5 high
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Altitude -1,100 ft to +18,000 ft (-340 m to +5,500m), Keep Dry, Do not stack more than 5 high
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Altitude -1,100 ft to +18,000 ft (-340 m to +5,500m), Keep Dry, Do not stack more than 5 high
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Altitude -1,100 ft to +18,000 ft (-340 m to +5,500m), Keep Dry, Do not stack more than 5 high
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Altitude -1,100 ft to +18,000 ft (-340 m to +5,500m), Keep Dry, Do not stack more than 5 high
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Altitude -1,100 ft to +18,000 ft (-340 m to +5,500m), Keep Dry, Do not stack more than 5 high
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Altitude -1,100 ft to +18,000 ft (-340 m to +5,500m), Keep Dry, Do not stack more than 5 high

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085412007021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102936

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: 2015-10-23

On-Brand Devices [HomeChoice APD System]

• 00085412007038: The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution
• 00085412007021: The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution