FDA.reportPublic FDA data

GOBEN

Primary DI
06979032640055
Brand
GOBEN
Company
HUZHOU JUNDA INDUSTRY CO., LTD.
Model
JD14-R430106
Device description
Guedel Airway - 90 mm Disposable Yellow
Published
2025-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BTQAirway, Nasopharyngeal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTQAirway, NasopharyngealAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16979032640052PackageGS150In Commercial Distribution
26979032640059PackageGS1250In Commercial Distribution
06979032640055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697903264005216979032640052
2697903264005926979032640059
06979032640055069790326400556979032640055

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
452976115
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06979032641168Thomas Jane MedicalTJM132026-06-27
06979032641175Thomas Jane MedicalTJM532026-06-27
06979032640017GOBENJD12-U0301012025-08-26
06979032640024GOBENJD13-H0401012025-08-26
06979032640031GOBENJD14-R4901072025-08-26
06979032640048GOBENJD14-R2801032025-08-26
06979032640062GOBENJD05-N0801022025-08-26
06979032640079GOBENJD04-C1401052025-08-26
06979032640086GOBENJD05-N0401022025-08-26
06979032640093GOBENJD05-N2301062025-08-26
06979032640109GOBENJD01-B0102032025-08-26
06979032640116GOBENJD14-R3901012025-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840118618298Endure IndustriesENDURE INDUSTRIESBTQ2026-08-14
00840118618304Endure IndustriesENDURE INDUSTRIESBTQ2026-08-14
00840118618311Endure IndustriesENDURE INDUSTRIESBTQ2026-08-14
00840118618328Endure IndustriesENDURE INDUSTRIESBTQ2026-08-14
00840118618335Endure IndustriesENDURE INDUSTRIESBTQ2026-08-14
00840118618342Endure IndustriesENDURE INDUSTRIESBTQ2026-08-14
14026704930187RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930194RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
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14026704930217RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930224RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930231RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930248RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930255RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930262RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930279RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930286RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930514RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930521RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930538RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930545RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930552RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930569RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930576RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930583RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930590RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930606RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930613RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930620RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930637RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28