FDA.reportPublic FDA data

Big Mouth™ Oral Airway with Balloon

Primary DI
10850027063017
Brand
Big Mouth™ Oral Airway with Balloon
Company
Wm & Dg, Inc.
Model
OA4100
Catalog number
OA4100
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.)
Published
2023-02-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
CAEAirway, Oropharyngeal, Anesthesiology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAEAirway, Oropharyngeal, AnesthesiologyAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850027063017PackageGS1130In Commercial Distribution
20850027063014PackageGS14In Commercial Distribution
00850027063010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002706301710850027063017
2085002706301420850027063014
00850027063010008500270630108500270630100850027063010

GMDN Terms#

Term, Definition table
TermDefinition
Oropharyngeal airway, single-useA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117870208
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850027066011TOAD™S-DVL2024-10-23
10850027066018TOAD™S-DVL2024-10-23
00850027061009TOAD™S-VW2024-08-07
00850027062112TOAD™S-VL-012024-08-07
00850027065953TOAD™DP102024-08-07
00850027060026TOADS-VLB2024-08-07
10850027061006TOAD™S-VW2024-08-07
10850027062119TOAD™S-VL-012024-08-07
10850027065950TOAD™DP102024-08-07
00850027063010Big Mouth™ Oral Airway with Balloon OA4100OA41002023-02-23
00850027063041Bougie Stylet B62400B624002023-02-23
00850027063027LIVVE™ Size 3.5LB1535LB15352023-02-23
00850027063034LIVVE™ Size 4.5LB1545LB15452023-02-23
10850027063048Bougie Stylet B62400B624002023-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05060112310072LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
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05060112310096LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310102LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310119LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310157LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310164LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310171LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310188LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310195LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310201LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310676LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
10888277699472MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-07-29
10888277699489MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-07-29
10888277699496MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-07-29
10888277699502MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-07-29
10888277699533MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-07-29
15060112314176LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
15060112316132LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
15060112316187LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
15060112316194LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
14026704945310RUSCHTELEFLEX INCORPORATEDCAE2026-07-24
14026704945327RUSCHTELEFLEX INCORPORATEDCAE2026-07-24
14026704945334RUSCHTELEFLEX INCORPORATEDCAE2026-07-24
14026704945341RUSCHTELEFLEX INCORPORATEDCAE2026-07-24
14026704945358RUSCHTELEFLEX INCORPORATEDCAE2026-07-24
14026704945365RUSCHTELEFLEX INCORPORATEDCAE2026-07-24
14026704945372RUSCHTELEFLEX INCORPORATEDCAE2026-07-24
14026704945389RUSCHTELEFLEX INCORPORATEDCAE2026-07-24