AccessGUDID - DEVICE: Big Mouth™ Oral Airway with Balloon (00850027063010)

GUDID

Device Identifier (DI) Information

Brand Name: Big Mouth™ Oral Airway with Balloon
Version or Model: OA4100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OA4100
Company Name: Wm & Dg, Inc.

Primary DI Number: 00850027063010
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117870208 *Terms of Use

Device Description: The Big Mouth™ Oral Airway with Balloon is a single-use, non-sterile, 2-lumen channel, flexible device intended to be used for maintaining an open airway and facilitating intubation in airway management for adults > 55kg (121 lbs.)

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?
42424	Oropharyngeal airway, single-use	A curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAE	Airway, Oropharyngeal, Anesthesiology

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: 2d3a4076-252c-47dd-abc0-bc52bac88e48
Public Version Date: March 03, 2023
Public Version Number: 1
DI Record Publish Date: February 23, 2023