Liberator

Basic Information

• Brand Name: Liberator
• Primary DI: M766206061860
• Version / Model: 20606186
• Company Name: CAIRE INC.
• Labeler DUNS: 807537683
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-25
• Public Version: 4
• Public Version Date: 2019-10-23
• Public Version Status: Update
• Public Device Record Key: 83bcf029-6856-48db-8c19-4b6f20c5bd3c

Device Description

Base Liquid Oxygen Respiratory Equipment, Dual Fill, 2 LPM, 20 PSI

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
BYJ	Unit, Liquid-Oxygen, Portable	Anesthesiology	868.5655	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35221	Stationary liquid oxygen container	An empty device designed as a large reservoir for the storage of liquid oxygen (LOX) prior to its distribution and use. It typically consists of a large capacity (e.g., 10 or 100 litres) double vessel bulk tank (i.e., an inner vessel to contain the liquid oxygen and an outer vessel for protection); vacuum in the space between both vessels provides thermal insulation for the LOX. The container typically includes evaporation coils that slowly boil the LOX into gas and is used in supply centres and in most large healthcare facilities before the distribution of LOX either as liquid or gas; some smaller containers are used at home to fill portable liquid oxygen units.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M766206061860	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K800742	000