CLEARLINK 2N8399

GUDID 50085412048890

Luer Activated Valve for IV Access

BAXTER INTERNATIONAL INC.

Catheter injection port

• Primary Device ID: 50085412048890
• NIH Device Record Key: 491826c7-7042-4bca-8f16-e629f96dade0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARLINK
• Version Model Number: 2N8399
• Catalog Number: 2N8399
• 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	00085412048895 [Primary]
GS1	50085412048890 [Package]; Contains: 00085412048895; Package: CASE [200 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112893

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 [CLEARLINK]

• 50085412565779: Paclitaxel Set, Polyethylene Lined Tubing, Non-DEHP Pump Segment, 0.2 Micron Downstream Filter,
• 50085412565762: Non-DEHP Solution Set, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar, 76"
• 50085412565670: Non-DEHP Solution Set, 1.2 Micron Downstream Filter, Luer Activated Valve, Male Luer Lock Adapte
• 50085412089411: Non-DEHP Catheter Extension Set Kit, 1 Catheter Extension Set, Luer Activated Valve for IV Acces
• 50085412089398: Non-DEHP Catheter Extension Set Kit, 1 Catheter Extension Set, Luer Activated Valve for IV Acces
• 50085412080951: Non-DEHP Extension Set, 0.2 Micron Downstream Filter, Luer Activated Valve, Male Luer Lock Adapt
• 50085412080944: Non-DEHP Extension Set, 2 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar
• 50085412074837: Y-Type Blood/Solution Set with Large Standard Blood Filter and Pressure Pump, 170 to 260 Micron
• 50085412074769: Non-DEHP Solution Set, 1.2 Micron Downstream Filter, Luer Activated Valve, Male Luer Lock Adapte
• 50085412072994: Straight Type Blood Set with standard blood filter, 170 to 260 Micron Filter Luer Activated Valv
• 50085412072987: Y-Type Blood/Solution Set with Large Standard Blood Filter, 170 to 260 Micron Filter, 2 Luer Act
• 50085412071713: 3-Port Manifold with Check Valves, Large Bore Stopcock Extension Set with Rotating Male Luer Loc
• 50085412071683: Paclitaxel Set, Polyethylene Lined Tubing, Non-DEHP Pump Segment, 0.2 Micron Filter Luer Activat
• 50085412071676: Large Bore Stopcock with Rotating Male Luer Lock, Extension Set, 2 Luer Activated Valves, Male L
• 20085412071651: Non-DEHP Three Lead Extension Set, Luer Activated Valve for I.V. Access, Male Luer Lock Adapter
• 50085412071195: Solution Set, 2 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar
• 50085412070051: Extension Set, 2 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar
• 50085412068386: Non-DEHP Solution Set, Hanger, Male Luer Lock Adapter
• 50085412068263: Blood Bag Spike Adapter, Luer Activated Valve for I.V. Access
• 50085412051722: Extension Set, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar
• 50085412051319: Non-DEHP Y-Type Catheter Extension Set, Luer Activated Valve for I.V. Access, Male Luer Lock Ada
• 50085412049095: Non-DEHP Solution Set, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar
• 50085412049088: Y-Type Blood/Solution Set with Standard Blood Filter, 170 to 260 Micron Filter, Luer Activated V
• 50085412049071: Y-Type Blood/Solution Set with Large Standard Blood Filter and Pressure Pump, 170 to 260 Micron
• 50085412049064: Secondary Medication Set, Hanger, Male Luer Lock Adapter
• 50085412049026: Extension Set, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar
• 50085412049019: Extension Set, 2 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar
• 50085412049002: Extension Set, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar
• 50085412048968: Extension Set, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar
• 50085412048944: Solution Set, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar
• 50085412048937: Solution Set, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar
• 50085412048920: Non-DEHP Y-Type Catheter Extension Set, 2 Luer Activated Valves, Male Luer Lock Adapter
• 50085412048913: Non-DEHP Catheter Extension Set, Luer Activated Valve for IV Access, Male Luer Lock Adapter with
• 50085412048906: Non-DEHP Catheter Extension Set, Luer Activated Valve for IV Access, Male Luer Lock Adapter
• 50085412048890: Luer Activated Valve for IV Access
• 50085412048500: Non-DEHP 3 Port Adapter, 2 Luer Activated Valves for IV Access, Male Luer Lock Adapter
• 50085412046438: Non-DEHP Extension Set, 1.2 Micron Filter, Luer Activated Valve, Male Luer Lock Adapter
• 50085412046414: Luer Activated Universal Vial Adapter
• 50085412046377: Vented Paclitaxel Set, Polyethylene Lined Tubing, Non-DEHP Pump Segment, 0.2 Micron Filter Luer
• 50085412046346: Y-Type Blood/Solution Set with Standard Blood Filter, 170 to 260 Micron Filter, Luer Activated V
• 50085412046339: Extension Set, 0.2 Micron Filter, Luer Activated Valve, Male Luer Lock Adapter with Retractable