CYCLER DRAINAGE BAG 5C4145NS

GUDID 57332414207934

The 15L Cycler Drainage Bag is not sterile product and is intended to serve as a container or device to collect (effluent) peritoneal cavity drainage from the drain line on Vantive Automated Peritoneal Dialysis (APD) Cycler Tubing Sets.

BAXTER HEALTHCARE CORPORATION

Peritoneal dialysis system tubing set

• Primary Device ID: 57332414207934
• NIH Device Record Key: cefcdc82-3f2e-4192-acb5-7d73e5a57091
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CYCLER DRAINAGE BAG
• Version Model Number: 5C4145NS
• Catalog Number: 5C4145NS
• Company DUNS: 005083209
• Company Name: BAXTER HEALTHCARE CORPORATION
• Device Count: 2
• DM Exempt: true
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com

Device Dimensions

• Total Volume: 15 Liter
• Total Volume: 15 Liter
• Total Volume: 15 Liter
• Total Volume: 15 Liter
• Total Volume: 15 Liter
• Total Volume: 15 Liter
• Total Volume: 15 Liter
• Total Volume: 15 Liter
• Total Volume: 15 Liter
• Total Volume: 15 Liter
• Total Volume: 15 Liter
• Total Volume: 15 Liter
• Total Volume: 15 Liter
• Total Volume: 15 Liter
• Total Volume: 15 Liter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room Temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085412722894 [Previous]
GS1	07332414207939 [Primary]
GS1	57332414207934 [Package]; Contains: 07332414207939; Package: CASE [30 Units]; In Commercial Distribution
GS1	70085412722893 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K214016

FDA Product Code

• KDJ: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-28
• Device Publish Date: 2025-03-20

On-Brand Devices [CYCLER DRAINAGE BAG]

• 50085412722899: The 15L Cycler Drainage Bag is not sterile product and is intended to serve as a container or de
• 57332414207934: The 15L Cycler Drainage Bag is not sterile product and is intended to serve as a container or de