AccessGUDID - DEVICE: AIR CUSHIONED FACE MASK (00718175005163)

GUDID

Device Identifier (DI) Information

Brand Name: AIR CUSHIONED FACE MASK
Version or Model: 132-685
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 132-685
Company Name: BIODEX MEDICAL SYSTEMS, INC.

Primary DI Number: 00718175005163
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 043833813 *Terms of Use

Device Description: MASK, FACE, LARGE ADULT, WITHOUT INJECTION PORT (LATEX FREE)

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:	Yes
Prescription Use (Rx):	No
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?
40908	Xenon administration system, diagnostic nuclear medicine	An assembly of devices which is considered to be a component of a nuclear medicine (NM) imaging system [e.g., a gamma camera or a single photon emission computed tomography (SPECT)] and is used as a rebreathing device to deliver gas to the patient and contain the exhaled radioactive xenon gas used during real-time imaging studies of lung function, blood flow or other physical or physiological parameters. It is designed to minimize release of radioactive gas into the working environment during imaging procedures.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYT	System, Rebreathing, Radionuclide

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: fe519169-6eae-4a8b-ad06-cdf9240bd91f
Public Version Date: December 23, 2019
Public Version Number: 1
DI Record Publish Date: December 13, 2019