FDA.reportPublic FDA data

KENTEX

Primary DI
00810003754691
Brand
KENTEX
Company
KENTRON HEALTHCARE, INC.
Model
550041
Device description
OXYGEN COUPLER OHMEDA TYPE WITH BARB CONNECTOR
Published
2024-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BZAConnector, Airway (Extension)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZAConnector, Airway (Extension)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810003754691PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810003754691008100037546918100037546910810003754691

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen quick-connect coupling, femaleA female connecting device used to accept a male oxygen (O2) connector to connect two devices together to provide a continuous passageway for the delivery of O2. It has safety features such as a specific mechanical mating pattern, colour coding and a dedicated tube diameter connection to prevent wrong connection and allow a user to rapidly connect and disconnect oxygen dependent devices. It can be attached, e.g., to an O2 regulator or an O2 extension tubing. It can be designed as a diameter-indexed safety system (DISS) connector or a non-interchangeable screw-threaded (NIST) connector. This is not an oxygen terminal unit.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
618825723
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810003750822KENTRON7599252026-06-08
00810003750839KENTRON7599302026-06-08
00810003750846KENTRON7599352026-06-08
00810003750853ENTRON7599402026-06-08
00810003750860KENTRON7599452026-06-08
00810003750877KENTRON7599502026-06-08
00810003750884KENTRON7599552026-06-08
00810003750891KENTRON7599602026-06-08
00810003750907KENTRON7599652026-06-08
00810003750709KENTRON7699502026-06-07
00810003750716KENTRON7699552026-06-07
00810003750723KENTRON7699602026-06-07
00810003750730KENTRON7699652026-06-07
00810003750747KENTRON7699702026-06-07
00810003750754KENTRON7699752026-06-07
00810003750761KENTRON7699802026-06-07
00810003750778KENTRON7699852026-06-07
00810003750785KENTRON7699902026-06-07
00810003750792KENTRON7699952026-06-07
00810003750808KENTRON7691002026-06-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344012039HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-07-06
10197344214792HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-05-18
10197344009800HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-03-19
10197344012008HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344012435HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344012466HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344012596HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344042326HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10889483225257AirLife™SUNMED, LLCBZA2025-12-22
10889483225226Adapters/ConnectorsSUNMED, LLCBZA2025-12-18
10889483225271AirLife™SUNMED, LLCBZA2025-12-18
10889483225660AirLife™SUNMED, LLCBZA2025-12-18
10197344012473HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2025-12-12
10197344042432HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2025-08-18
10884521854147DARCovidien LPBZA2025-08-10
10884521084995DARCovidien LPBZA2025-04-12
10884521842533DARCovidien LPBZA2025-04-12
10884522019743DARCovidien LPBZA2025-04-12
10884522019750DARCovidien LPBZA2025-04-12
10884522019774DARCovidien LPBZA2025-04-12
10884522019781DARCovidien LPBZA2025-04-12
10884522019804DARCovidien LPBZA2025-04-12
10884522019811DARCovidien LPBZA2025-04-12
10884522019828DARCovidien LPBZA2025-04-12
10884522019835DARCovidien LPBZA2025-04-12
10884522019842DARCovidien LPBZA2025-04-12
10884522019859DARCovidien LPBZA2025-04-12
10884522019866DARCovidien LPBZA2025-04-12
10884522019873DARCovidien LPBZA2025-04-12
10884522019880DARCovidien LPBZA2025-04-12