Cycler Drainage Bag 5C4145NS

GUDID 50085412722899

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 Baxter Automated Peritoneal Dialysis (APD) Cycler Tubing Sets.

BAXTER HEALTHCARE CORPORATION

Peritoneal dialysis system tubing set

• Primary Device ID: 50085412722899
• NIH Device Record Key: 3606a169-9de4-49f6-b267-938ad46876f8
• 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: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: 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
• 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
• 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
• 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
• 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 [Primary]
GS1	50085412722899 [Package]; Contains: 00085412722894; Package: CA [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: 2022-10-03
• Device Publish Date: 2022-09-23

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