CLEARLINK/CONTROL-A-FLO

Basic Information

• Brand Name: CLEARLINK/CONTROL-A-FLO
• Primary DI: 00085412046396
• Version / Model: 2C8891
• Catalog Number: 2C8891
• 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: 4
• Public Version Date: 2020-06-05
• Public Version Status: Update
• Public Device Record Key: e7e50e19-32e9-473d-92a7-685e33304bd9

Device Description

Extension Set with CONTROL-A-FLO Regulator, 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
FPA	Set, administration, intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35894	Medical tubing clip/clamp, temporary, dial-calibrated	A non-sterile manual device designed to control the infusion rate through gravity intravenous administration infusion sets. It typically consists of a mechanism that regulates the flow using a calibrated dial that permits control of the flow rate in a given range (e.g., from a few to 250 ml/h); it may also include a lateral clamp for temporary interruption of the infusion and/or a check valve to permit parallel infusion. The device is used in-line with gravity infusion administration sets. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50085412046391	GS1	CASE	48	In Commercial Distribution
Primary	00085412046396	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K121634	000