AccessGUDID - DEVICE: SILICONE CUSHION MASK SIZE#5 (04716770862514)

GUDID

Device Identifier (DI) Information

Brand Name: SILICONE CUSHION MASK SIZE#5
Version or Model: SM-86251
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BESMED HEALTH BUSINESS CORP.

Primary DI Number: 04716770862514
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 658023775 *Terms of Use

Device Description: SILICONE CUSHION MASK SIZE#5

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:	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?
36066	Cardiopulmonary resuscitation mask, reusable	A flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace "mouth-to-mouth" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGB	Mask, Oxygen, Non-Rebreathing

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: da4e6e8b-eb89-495e-b366-4b4e4d592ab3
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: December 28, 2017