LIFE®Cylinder

Basic Information

• Brand Name: LIFE®Cylinder
• Primary DI: B188LIFE21010
• Version / Model: LIFE-2-101
• Company Name: LIFE CORPORATION
• Labeler DUNS: 151860053
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-29
• Public Version: 3
• Public Version Date: 2021-03-10
• Public Version Status: Update
• Public Device Record Key: c0fbc359-1986-45b0-ad82-595f70424b46

Device Description

LIFE®SoftPac replacement/spare cylinder. Includes cylinder, valve, gauge, and 255 liters of oxygen. Provides 40 minute supply of oxygen at 6 LPM.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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: No
• 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
ECX	Cylinder, Compressed Gas, And Valve	Anesthesiology	868.2700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47225	Oxygen refillable cylinder	A container designed as a refillable cylinder used to hold compressed medical oxygen (O2) under safe conditions at high pressure (e.g., 50 - 200 Bar). It is typically filled with O2 when delivered from the gas supplier and includes a valve stem, an opening/closing valve, and will be graded according to size (capacity) and colour-coded to denote O2 content. The cylinder may be made of steel, aluminium (Al) or other ferrous or non-ferrous materials and must be used together with a pressure regulator in order to release the O2 at the correct working pressure. O2 is used as an essential life support gas, for anaesthesia, and for therapeutic purposes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B188LIFE21010	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	255	Liter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 125 Degrees Fahrenheit