B.BRAUN

Basic Information

• Brand Name: B.BRAUN
• Primary DI: 04046964775031
• Version / Model: 7B3105
• Catalog Number: 7B3105
• Company Name: B. BRAUN MEDICAL INC.
• Labeler DUNS: 002397347
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2020-11-06
• Public Version Status: Update
• Public Device Record Key: fe542f74-c3de-4f06-aa03-8831f6c7d451

Device Description

VENTED SPIKE WITH AIF

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
LHI	Set, i.V. Fluid transfer	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64996	Luer-formatted bag access spike	A small, noninvasive, tubular connector with a Luer connection (either lock or slip) at one end, and a hollow spike (either blunt or sharp) at the other end, intended to connect an intravenous (IV) fluid or blood bag to a fluid line or syringe for administration to a patient; it may in addition be used to draw medication from a vial, however it is not a vial/bottle adaptor. It may include an additional administration port (i.e., Y-site device), a built-in air filter, retention clamp, or valve(s); it does not however include tubing (i.e., not a tubing set). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04046964775031	GS1
Unit of Use	04046964775024	GS1

Customer Contacts

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