ACT6227

GUDID 50085412079726

Extension Set, Male Luer Lock Adapter with Retractable Collar

BAXTER INTERNATIONAL INC.

Intravenous administration tubing extension set

• Primary Device ID: 50085412079726
• NIH Device Record Key: 516584ec-4bba-4b6f-9520-e625238da980
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: ACT6227
• Catalog Number: ACT6227
• 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	00085412079721 [Primary]
GS1	50085412079726 [Package]; Contains: 00085412079721; Package: CASE [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142011

FDA Product Code

• FPA: Set, administration, intravascular

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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