Effluent Sample Bag 5C4476

GUDID 50085412007712

This bag is intended to collect sample drainage of peritoneal dialysis effluent from Baxter Peritoneal Dialysis Tubing Sets and is intended for use with Luer connector products.

BAXTER INTERNATIONAL INC.

Peritoneal dialysis system tubing set

• Primary Device ID: 50085412007712
• NIH Device Record Key: e4faaf8b-3b92-4870-9a36-0156a0e55fb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Effluent Sample Bag
• Version Model Number: 5C4476
• Catalog Number: 5C4476
• Company DUNS: 005146311
• Company Name: BAXTER INTERNATIONAL 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: true
• 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
• 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
• 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

• 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
• 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	00085412007717 [Primary]
GS1	50085412007712 [Package]; Contains: 00085412007717; Package: CASE [6 Units]; In Commercial Distribution
GS1	80085412007713 [Package]; Package: CARTON [108 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923065

FDA Product Code

• FKX: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

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