114423

GUDID 57332414112269

A6001 5L Effluent Bag

GAMBRO UF SOLUTIONS, INC

Extracorporeal circuit waste bag, sterile

• Primary Device ID: 57332414112269
• NIH Device Record Key: f13cdf34-8118-474e-b892-798714293f67
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 114423
• Catalog Number: 114423
• Company DUNS: 132629788
• Company Name: GAMBRO UF SOLUTIONS, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• 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

Device Dimensions

• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, between 32 Deg. F and 86 Deg. F
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, between 32 Deg. F and 86 Deg. F
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, between 32 Deg. F and 86 Deg. F
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, between 32 Deg. F and 86 Deg. F
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, between 32 Deg. F and 86 Deg. F
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, between 32 Deg. F and 86 Deg. F
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, between 32 Deg. F and 86 Deg. F
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, between 32 Deg. F and 86 Deg. F
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, between 32 Deg. F and 86 Deg. F
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, between 32 Deg. F and 86 Deg. F
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, between 32 Deg. F and 86 Deg. F
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, between 32 Deg. F and 86 Deg. F
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, between 32 Deg. F and 86 Deg. F

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332414112264 [Primary]
GS1	57332414112269 [Package]; Contains: 07332414112264; Package: CASE [50 Units]; In Commercial Distribution

FDA Product Code

• MON: SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-29
• Device Publish Date: 2018-09-28

Devices Manufactured by GAMBRO UF SOLUTIONS, INC

• 57332414118919 - AUTO EFFLUENT SET: 2025-08-26 The Auto Effluent Accessory is indicated for use only with the PrisMax control unit in providing automatic effluent draining dur
• 57332414112269 - NA: 2018-10-29A6001 5L Effluent Bag
• 57332414112269 - NA: 2018-10-29 A6001 5L Effluent Bag
• 07332414112301 - Aquadex FlexFlow: 2018-03-29 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have
• 27332414112367 - Dual Lumen Extended Length Catheter: 2018-03-29 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have
• 37332414112371 - Blood Circuit Set: 2018-03-29 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have
• 37332414112388 - Blood Circuit Set: 2018-03-29 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have
• 37332414119325 - Dual Lumen Extended Length Catheter and GALT inser: 2018-03-29 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have