2N3347

GUDID 50085412004810

Non-DEHP MICRO-VOLUME Extension Set, 0.2 Micron Downstream Filter, Male Luer Lock Adapter

BAXTER INTERNATIONAL INC.

Intravenous line filter

• Primary Device ID: 50085412004810
• NIH Device Record Key: cacb9894-227c-4eca-a502-9534ecefda19
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 2N3347
• Catalog Number: 2N3347
• 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: true
• Labeled No Natural Rubber Latex: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085412004815 [Primary]
GS1	50085412004810 [Package]; Contains: 00085412004815; Package: CASE [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113227

FDA Product Code

• FPB: Filter, infusion line

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-08
• Device Publish Date: 2016-09-24

Devices Manufactured by BAXTER INTERNATIONAL INC.

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• 50085412065293 - INTERLINK: 2020-06-30 Y-Type Blood/Solution Set with 40 and 150 Micron Dual Screen Filter and Pressure Pump, Injection Site, Male Luer Lock Adapter wi
• 50085412046162 - NA: 2020-05-06 Evacuated Container, 1000 mL
• 50085412565625 - NA: 2019-12-11 Non-DEHP IV Fat Emulsion Administration Set, Male Luer Lock Adapter with Retractable Collar
• 50085412565946 - NA: 2019-12-11 Non-DEHP IV Fat Emulsion Administration Set, Male Luer Lock Adapter with Retractable Collar
• 50085412000522 - INTERLINK/CONTINU-FLO: 2019-12-11 Non-DEHP CONTINU-FLO Solution Set, 2 Injection Sites, Male Luer Lock Adapter with Retractable Collar