AccessGUDID - DEVICE: LIFE®OxygenPac (B188LIFE6120)

GUDID

Device Identifier (DI) Information

Brand Name: LIFE®OxygenPac
Version or Model: LIFE-612
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Mv Life LLC

Primary DI Number: B188LIFE6120
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 096584064 *Terms of Use

Device Description: LIFE®OxygenPac is an easily portable, wall-mounted Emergency Oxygen Unit. A 6&12 LPM (NORM & HIGH), variable-flow regulator provides a 90 minute supply of oxygen at 6LPM.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
31760	Fixed-regulator oxygen refillable cylinder	A container designed as a refillable cylinder with an integrated pressure regulator 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 built-in pressure regulator that, when activated, releases the O2 at the correct working pressure. It is available in some cylinder sizes (capacity) and colour-coded to denote O2 content. The cylinder may be made of steel, aluminium (Al) or other ferrous or non-ferrous materials. O2 is used as an essential life support gas, for anaesthesia, and for therapeutic purposes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAN	Regulator, Pressure, Gas Cylinder

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 125 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 566 Liter

Device Record Status

Public Device Record Key: fe77df7c-5944-4902-8840-fd9f6eb5334a
Public Version Date: September 16, 2024
Public Version Number: 4
DI Record Publish Date: June 29, 2016