ONE-LINK 7N8377

GUDID 50085412091803

Non-DEHP Y-Type Standard Bore Catheter Extension Set, Needle-free IV Connector with Neutral Fluid Displacement, Male Luer Lock Adapter with Retractable Collar

BAXTER INTERNATIONAL INC.

Intravenous administration tubing extension set

• Primary Device ID: 50085412091803
• NIH Device Record Key: 2b8ebd44-dfc1-4eb7-a0d0-dcc53911f0e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONE-LINK
• Version Model Number: 7N8377
• Catalog Number: 7N8377
• 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	00085412091808 [Primary]
GS1	50085412091803 [Package]; Contains: 00085412091808; Package: CASE [200 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132734

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

On-Brand Devices [ONE-LINK]

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• 50085412613487: One-Link Non-DEHP 3 Lead Standard Bore Catheter Extension Set Bonded Needle-free IV Connector wi
• 50085412613470: One-Link Non-DEHP Y-Type Standard Bore Catheter Extension Set Bonded Needle-free IV Connector wi
• 50085412599750: One-Link Non-DEHP Standard Bore Catheter Extension Set Bonded Needle-free IV Connector with Neut
• 50085412599620: One-Link Non-DEHP 3 Lead Microbore Catheter Extension Set Needle-free IV Connector with Neutral
• 50085412599613: One-Link Non-DEHP 3 Lead Standard Bore Catheter Extension Set Needle-free IV Connector with Neut
• 50085412599606: One-Link Non-DEHP Y-Type Standard Bore Catheter Extension Set Needle-free IV Connector with Neut
• 50085412476723: Non-DEHP Microbore Catheter Extension Set, Needle-free IV Connector with Neutral Fluid Displacem
• 50085412475412: Non-DEHP Microbore Catheter Extension Set, Bonded Needle-free IV Connector with Neutral Fluid Di
• 50085412475405: Non-DEHP Standard Bore Catheter Extension Set, Bonded Needle-free IV Connector with Neutral Flui
• 50085412475382: Non-DEHP Standard Bore Catheter Extension Set, Needle-free IV Connector with Neutral Fluid Displ
• 50085412091834: Non-DEHP Microbore Catheter Extension Set, Needle-free IV Connector with Neutral Fluid Displacem
• 50085412091827: Non-DEHP Y-Type Microbore Catheter Extension Set, Needle-free IV Connectors with Neutral Fluid D
• 50085412091803: Non-DEHP Y-Type Standard Bore Catheter Extension Set, Needle-free IV Connector with Neutral Flui
• 50085412091797: Non-DEHP Standard Bore Catheter Extension Set, Needle-free IV Connector with Neutral Fluid Displ
• 50085412091780: Needle-free IV Connector with Neutral Fluid Displacement, Power Injectable