APD Drain Manifold 5C4512

GUDID 50085412007750

This set is designed to allow drainage of peritoneal dialysis effluent from the drain line on an automated peritoneal dialysis cycler tubing set into 2 drain bags.

BAXTER INTERNATIONAL INC.

Peritoneal dialysis system tubing set

• Primary Device ID: 50085412007750
• NIH Device Record Key: 2b3f41a4-588b-4721-8279-200f34db5907
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APD Drain Manifold
• Version Model Number: 5C4512
• Catalog Number: 5C4512
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085412007755 [Primary]
GS1	50085412007750 [Package]; Contains: 00085412007755; Package: CASE [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K791899

FDA Product Code

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

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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