Vivo 50, Vivo 65, Vivo 45 LS

Basic Information

• Brand Name: Vivo 50, Vivo 65, Vivo 45 LS
• Primary DI: 07321820050321
• Version / Model: 005032
• Catalog Number: 005032
• Company Name: Breas Medical AB
• Labeler DUNS: 357007657
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-18
• Public Version: 2
• Public Version Date: 2022-12-26
• Public Version Status: Update
• Public Device Record Key: db451dd0-137e-4e39-9f7f-15f00e31c368

Device Description

Oxygen adapter low pressure

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: 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	868.5895	2
NOU	Continuous, Ventilator, Home Use	Anesthesiology	868.5895	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37038	Ventilator converter	A device intended to be used to couple together any type of powered ventilator to any kind of breathing circuit system, making them compatible for use. By using this device it is then possible to use alternative combinations of ventilator and breathing circuit from different manufacturers. This will assist, e.g., a hospital to be flexible in the choice of breathing circuit or system and allowing for the introduction to new kinds whilst the ventilators may remain the same. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07321820050321	GS1

Customer Contacts

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