V-LINK/VITALSHIELD 6N8399

GUDID 50085412088308

V-LINK, Luer Activated Device with VITALSHIELD Protective Coating

BAXTER INTERNATIONAL INC.

Catheter injection port

• Primary Device ID: 50085412088308
• NIH Device Record Key: 792c1143-e24f-4f6c-a809-535d6830e78a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V-LINK/VITALSHIELD
• Version Model Number: 6N8399
• Catalog Number: 6N8399
• Company DUNS: 005146311
• Company Name: BAXTER INTERNATIONAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085412088303 [Primary]
GS1	50085412088308 [Package]; Contains: 00085412088303; Package: CASE [200 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081289

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 [V-LINK/VITALSHIELD]

• 50085412088346: V-LINK, Non-DEHP Catheter Extension Set, Luer Activated Device with VITALSHIELD Protective Coati
• 50085412088322: V-LINK, Non-DEHP Catheter Extension Set, Luer Activated Device with VITALSHIELD Protective Coati
• 50085412088308: V-LINK, Luer Activated Device with VITALSHIELD Protective Coating