CLEARLINK/CONTINU-FLO 2H8454

GUDID 50085412090127

Non-DEHP CONTINU-FLO Solution Set, 2 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar, Non-DEHP Large Bore Stopcock Extension Set, Large Bore Stopcock Manifold, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar

BAXTER INTERNATIONAL INC.

Intravenous line stopcock

• Primary Device ID: 50085412090127
• NIH Device Record Key: 3ea803b0-2fe6-4559-8a0d-3418d6a4246c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARLINK/CONTINU-FLO
• Version Model Number: 2H8454
• Catalog Number: 2H8454
• 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	00085412090122 [Primary]
GS1	50085412090127 [Package]; Contains: 00085412090122; Package: CASE [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130245

FDA Product Code

• FMG: Stopcock, i.V. Set

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 [CLEARLINK/CONTINU-FLO]

• 50085412565748: Non-DEHP CONTINU-FLO Solution Set, 3 Luer Activated Valves, Male Luer Lock Adapter with Retracta
• 50085412565694: Non-DEHP CONTINU-FLO Solution Set, 3 Luer Activated Valves, Male Luer Lock Adapter with Retracta
• 50085412565687: Non-DEHP CONTINU-FLO Solution Set, 2 Luer Activated Valves, Male Luer Lock Adapter with Retracta
• 50085412565649: Non-DEHP CONTINU-FLO Solution Set, 68" 1.7m approx., 2 Luer Activated Valves, Male Luer Lock Ada
• 50085412090127: Non-DEHP CONTINU-FLO Solution Set, 2 Luer Activated Valves, Male Luer Lock Adapter with Retracta
• 50085412080920: Non-DEHP CONTINU-FLO Solution Set, 3 Luer Activated Valves, Male Luer Lock Adapter with Retracta
• 50085412080906: Non-DEHP CONTINU-FLO Solution Set, 3 Luer Activated Valves, Male Luer Lock Adapter with Retracta
• 50085412079672: CONTINU-FLO Solution Set, 0.2 Micron Downstream Filter, Luer Activated Valve, Male Luer Lock Ada
• 50085412077449: CONTINU-FLO Solution Set, 3 Luer Activated Valves, Male Luer Lock Adapter with Retractable Colla
• 50085412076299: CONTINU-FLO Solution Set, 2 Luer Activated Valves, Male Luer Lock Adapter, Large Bore Stopcock M
• 50085412074424: CONTINU-FLO Solution Set, 3 Luer Activated Valves, Male Luer Lock Adapter, Extension Set, 2 Luer
• 50085412073687: CONTINU-FLO Solution Set, 2 Luer Activated Valves, Male Luer Lock Adapter with Retractable Colla
• 50085412071720: CONTINU-FLO Solution Set, 2 Luer Activated Valves, Male Luer Lock Adapter, 3-Port Manifold with
• 50085412071669: CONTINU-FLO Solution Set, 0.2 Micron Downstream Filter, 3 Luer Activated Valves, Male Luer Lock
• 50085412071119: Vented CONTINU-FLO Solution Set, 2 Luer Activated Valves, Male Luer Lock Adapter with Retractabl
• 50085412051708: CONTINU-FLO Solution Set, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar
• 50085412048999: CONTINU-FLO Solution Set, 2 Luer Activated Valves, Male Luer Lock Adapter with Retractable Colla
• 50085412048982: CONTINU-FLO Solution Set, 3 Luer Activated Valves, Male Luer Lock Adapter with Retractable Colla
• 50085412048975: CONTINU-FLO Solution Set, 3 Luer Activated Valves, Male Luer Lock Adapter with Retractable Colla
• 50085412048456: Non-DEHP CONTINU-FLO Solution Set, 2 Luer Activated Valves, Male Luer Lock Adapter with Retracta
• 50085412046322: CONTINU-FLO Solution Set, 0.2 Micron Filter, 2 Luer Activated Valves, Male Luer Lock Adapter wit
• 50085412046315: CONTINU-FLO Solution Set, 2 Luer Activated Valves, Male Luer Lock Adapter with Retractable Colla
• 50085412046308: CONTINU-FLO Solution Set, 2 Luer Activated Valves, Male Luer Lock Adapter with Retractable Colla
• 50085412045394: CONTINU-FLO Solution Set, 2 Luer Activated Valves, Male Luer Lock Adapter with Retractable Colla