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

Device Identifier (DI) Information

Big Mouth™ Oral Airway with Balloon
OA4100
In Commercial Distribution
OA4100
Wm & Dg, Inc.
00850027063010
GS1

1
117870208 *Terms of Use
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.)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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
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FDA Product Code

[?]
Product Code Product Code Name
CAE Airway, Oropharyngeal, Anesthesiology
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

2d3a4076-252c-47dd-abc0-bc52bac88e48
March 03, 2023
1
February 23, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10850027063017 130 00850027063010 In Commercial Distribution Box
20850027063014 4 10850027063017 In Commercial Distribution Carton
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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