AccessGUDID - DEVICE: HI-OXYGEN MASK ADULT, WITH 7FT TUBE (UNIVERSAL CONNECTOR ON ONE SIDE),SINGLE PA (04716770812113)

GUDID

Device Identifier (DI) Information

Brand Name: HI-OXYGEN MASK ADULT, WITH 7FT TUBE (UNIVERSAL CONNECTOR ON ONE SIDE),SINGLE PA
Version or Model: OM-81211
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: BESMED HEALTH BUSINESS CORP.

Primary DI Number: 04716770812113
Issuing Agency: GS1
Commercial Distribution End Date: December 20, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 658023775 *Terms of Use

Device Description: HI-OXYGEN MASK ADULT, WITH 7FT TUBE (UNIVERSAL CONNECTOR ON ONE SIDE),SINGLE PACKING

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":	Yes
For Single-Use:	Yes
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?
37498	Respiratory oxygen therapy system	An assembly of devices designed to be interconnected to administer oxygen (O2) to a patient using various methods of oxygen administration (e.g., face mask, nasal canula) at different concentrations (e.g., via a gas mixer), duration of use, and flows. It will connect to an oxygen source and will typically include a flowmeter or flow controlling device, masks, tubing, valves, and/or nasal cannulae. It can also include, e.g., a high pressure gas reduction valve(s) and a pneumatically-powered suction device with collection bottle.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
BYG	Mask, Oxygen

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 727ddf2a-2b2d-4999-8c3c-4ff7202fdba2
Public Version Date: July 12, 2019
Public Version Number: 3
DI Record Publish Date: December 20, 2017