CLEARLINK/CONTINU-FLO

Basic Information

• Brand Name: CLEARLINK/CONTINU-FLO
• Primary DI: 00085412090122
• Version / Model: 2H8454
• Catalog Number: 2H8454
• Company Name: BAXTER INTERNATIONAL INC.
• Labeler DUNS: 005146311
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 3ea803b0-2fe6-4559-8a0d-3418d6a4246c

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMG	Stopcock, i.V. Set	General Hospital	880.5440	2
FPA	Set, administration, intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32172	Intravenous line stopcock	A sterile valve that is typically a component of an intravenous (IV) administration set and designed to be manually-operated by healthcare staff to regulate the flow of intravenous solution delivered to a patient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50085412090127	GS1	CASE	48	In Commercial Distribution
Primary	00085412090122	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K130245	000