NA

Basic Information

• Brand Name: NA
• Primary DI: 04046964349966
• Version / Model: 7M2803
• Catalog Number: 7M2803
• Company Name: B. BRAUN MEDICAL INC.
• Labeler DUNS: 002397347
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2020-05-19
• Public Version Status: Update
• Public Device Record Key: 32ff3a58-80ca-445b-be46-febce922a900

Device Description

INAMED BLISTERED REFLUX VALVE ASSEMBLY

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: Yes
• 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
MEA	Pump, infusion, pca	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42743	Negative-pressure intravenous line needleless valve-connector	A small, stand-alone, Luer-activated needleless plastic valve intended to mate two related intravenous (IV) line devices [e.g., hypodermic syringe and catheter port or tubing from an IV administration set] and hold them in a secured, sealed, locked position until disconnection, at which point negative pressure from the device causes a small volume of retrograde fluid flow into the catheter/tubing. It is intended to eliminate the use of needles for IV administration of medications. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04046964349966	GS1
Unit of Use	04046964349942	GS1

Customer Contacts

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