INTERLINK/BURETROL 3C0166

GUDID 50085412078217

BURETROL Solution Set, 150 mL Burette Drip Chamber Filter Valve, 2 Injection Sites, Male Luer Lock Adapter, Large Bore Stopcock with Rotating Male Luer Lock Extension Set, Injection Site, Male Luer Lock Adapter with Retractable Collar

BAXTER INTERNATIONAL INC.

Burette intravenous administration set

• Primary Device ID: 50085412078217
• NIH Device Record Key: 82b2bbae-ec00-4a77-8358-e18f859d9bd7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTERLINK/BURETROL
• Version Model Number: 3C0166
• Catalog Number: 3C0166
• 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
• 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	00085412078212 [Primary]
GS1	50085412078217 [Package]; Contains: 00085412078212; Package: CASE [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123874

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 [INTERLINK/BURETROL]

• 50085412078217: BURETROL Solution Set, 150 mL Burette Drip Chamber Filter Valve, 2 Injection Sites, Male Luer Lo
• 50085412075292: Non-DEHP BURETROL Solution Set, 150 mL Valveless Burette, 4 Injection Sites, Male Luer Lock Adap
• 50085412068201: BURETROL Add-On Set, 150 mL Valveless Burette, Injection Site, Slide Clamp
• 50085412050695: BURETROL Solution Set, 150 mL Valveless Burette, 4 Injection Sites, Male Luer Lock Adapter with
• 50085412002786: BURETROL Solution Set, 150 mL Burette Drip Chamber Filter Valve, 3 Injection Sites, Male Luer Lo