1C8732

GUDID 50085412079535

Y-Type Blood/Solution Set with Standard Blood Filter, 170 to 260 Micron Filter, Male Luer Lock Adapter with Retractable Collar

BAXTER INTERNATIONAL INC.

Blood transfusion set

• Primary Device ID: 50085412079535
• NIH Device Record Key: 3bb11795-5c1e-4952-8ac9-edeacb7fa38e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 1C8732
• Catalog Number: 1C8732
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085412079530 [Primary]
GS1	50085412079535 [Package]; Contains: 00085412079530; Package: CASE [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993120

FDA Product Code

• BRZ: Set, blood transfusion

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: 2016-09-24

Devices Manufactured by BAXTER INTERNATIONAL INC.

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