AccessGUDID - DEVICE: Rescuer O-Mask with Universal Oxygen Tubing (Small Adult) (B0026205U0)

GUDID

Device Identifier (DI) Information

Brand Name: Rescuer O-Mask with Universal Oxygen Tubing (Small Adult)
Version or Model: 6205-U
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6205-U
Company Name: B.L.S. Systems Limited

Primary DI Number: B0026205U0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 200103823 *Terms of Use

Device Description: Rescuer O-Mask with Universal Oxygen Tubing (Small Adult)

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):	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?
35173	Non-rebreathing oxygen face mask	A non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver air of high oxygen (O2) concentration to a patient's airway. It typically includes two unidirectional valves, one that closes during inspiration to prevent room air mixing with oxygen in a reservoir bag, and one that closes during exhalation to prevent exhaled respiratory gases from entering the reservoir bag. It is made of soft, flexible polymers designed to create an airtight seal against the patient's face. It may include tubing, and various valves and connectors, however other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use 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
Device Size Text, specify: Small Adult

Device Record Status

Public Device Record Key: 43193c7e-b895-4898-8671-be7c610bbfb6
Public Version Date: April 09, 2021
Public Version Number: 1
DI Record Publish Date: April 01, 2021