BROSELOW™

Basic Information

• Brand Name: BROSELOW™
• Primary DI: 10190752157873
• Version / Model: 7700GIN
• Catalog Number: 7700GIN
• Company Name: VYAIRE MEDICAL, INC.
• Labeler DUNS: 080456871
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-20
• Public Version: 1
• Public Version Date: 2021-07-28
• Public Version Status: New
• Public Device Record Key: 9c71cb37-0847-43ae-bd1b-dd6d6eee1c8a

Device Description

INTUBATION MODULES

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OKI	Emergency response safety kit	General, Plastic Surgery	878.4040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43000	First aid kit, non-medicated, reusable	A convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and other public settings. This device does not contain medicinal substances/pharmaceuticals. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50190752157871	GS1	CASE	40	In Commercial Distribution
Primary	10190752157873	GS1

Customer Contacts

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