AccessGUDID - DEVICE: Liberator (M766132594920)

GUDID

Device Identifier (DI) Information

Brand Name: Liberator
Version or Model: 13259492
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CAIRE INC.

Primary DI Number: M766132594920
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 807537683 *Terms of Use

Device Description: Base Liquid Oxygen Respiratory Equipment, Top Fill, 15 LPM, 20 PSI

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):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYJ	Unit, Liquid-Oxygen, Portable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K800742	000

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1491a382-2578-4929-962a-02c385dc4e12
Public Version Date: October 23, 2019
Public Version Number: 4
DI Record Publish Date: August 25, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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