Blood Circuit Set 114157

GUDID 37332414112371

The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic thera

GAMBRO UF SOLUTIONS, INC

Haemofilter

• Primary Device ID: 37332414112371
• NIH Device Record Key: f1258b9f-380d-46e3-b0c0-9c09a0f3e93c
• Commercial Distribution Discontinuation: 2017-07-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Blood Circuit Set
• Version Model Number: UF 500-HCT
• Catalog Number: 114157
• Company DUNS: 132629788
• Company Name: GAMBRO UF SOLUTIONS, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
• 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 Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332414112370 [Primary]
GS1	37332414112371 [Package]; Contains: 07332414112370; Package: CASE [5 Units]; Discontinued: 2017-07-14; Not in Commercial Distribution

FDA Product Code

• KDI: Dialyzer, high permeability with or without sealed dialysate system

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-09-29

On-Brand Devices [Blood Circuit Set]

• 37332414112388: The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patie
• 37332414112371: The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patie