HomeChoice APD System 5C4471R

GUDID 00085412007038

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
Primary Device ID00085412007038
NIH Device Record Keyc2c291de-fd3b-4565-a6ae-19a4ecc5f4c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameHomeChoice APD System
Version Model Number5C4471R
Catalog Number5C4471R
Company DUNS005146311
Company NameBAXTER INTERNATIONAL INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Stacking limit; do not stack more than 5 high
Special Storage Condition, SpecifyBetween 0 and 0 *Stacking limit; do not stack more than 5 high
Special Storage Condition, SpecifyBetween 0 and 0 *Stacking limit; do not stack more than 5 high
Special Storage Condition, SpecifyBetween 0 and 0 *Stacking limit; do not stack more than 5 high
Special Storage Condition, SpecifyBetween 0 and 0 *Stacking limit; do not stack more than 5 high
Special Storage Condition, SpecifyBetween 0 and 0 *Stacking limit; do not stack more than 5 high
Special Storage Condition, SpecifyBetween 0 and 0 *Stacking limit; do not stack more than 5 high
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Altitude -1,100 ft to +18,000 ft (-340 m to +5,500m)
Special Storage Condition, SpecifyBetween 0 and 0 *Stacking limit; do not stack more than 5 high
Storage Environment TemperatureBetween -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Altitude -1,100 ft to +18,000 ft (-340 m to +5,500m)
Special Storage Condition, SpecifyBetween 0 and 0 *Stacking limit; do not stack more than 5 high
Storage Environment TemperatureBetween -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Altitude -1,100 ft to +18,000 ft (-340 m to +5,500m)
Special Storage Condition, SpecifyBetween 0 and 0 *Stacking limit; do not stack more than 5 high
Storage Environment TemperatureBetween -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Altitude -1,100 ft to +18,000 ft (-340 m to +5,500m)
Special Storage Condition, SpecifyBetween 0 and 0 *Stacking limit; do not stack more than 5 high
Storage Environment TemperatureBetween -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Altitude -1,100 ft to +18,000 ft (-340 m to +5,500m)
Special Storage Condition, SpecifyBetween 0 and 0 *Stacking limit; do not stack more than 5 high
Storage Environment TemperatureBetween -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Altitude -1,100 ft to +18,000 ft (-340 m to +5,500m)
Special Storage Condition, SpecifyBetween 0 and 0 *Stacking limit; do not stack more than 5 high
Storage Environment TemperatureBetween -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Altitude -1,100 ft to +18,000 ft (-340 m to +5,500m)
Special Storage Condition, SpecifyBetween 0 and 0 *Stacking limit; do not stack more than 5 high
Storage Environment TemperatureBetween -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Altitude -1,100 ft to +18,000 ft (-340 m to +5,500m)
Special Storage Condition, SpecifyBetween 0 and 0 *Stacking limit; do not stack more than 5 high
Storage Environment TemperatureBetween -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Altitude -1,100 ft to +18,000 ft (-340 m to +5,500m)
Special Storage Condition, SpecifyBetween 0 and 0 *Stacking limit; do not stack more than 5 high
Storage Environment TemperatureBetween -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Altitude -1,100 ft to +18,000 ft (-340 m to +5,500m)
Special Storage Condition, SpecifyBetween 0 and 0 *Stacking limit; do not stack more than 5 high
Storage Environment TemperatureBetween -25 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Fahrenheit and 130 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100085412007038 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FKXSYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-23

On-Brand Devices [HomeChoice APD System]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.