FDA.reportPublic FDA data

KENOREX

Primary DI
00810003755919
Brand
KENOREX
Company
KENTRON HEALTHCARE, INC.
Model
381120
Device description
ANESTHESIA MASK WITH PRE INFLATED CUSHION PEDIATRIC SIZE 2
Published
2026-05-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSJMask, Gas, Anesthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSJMask, Gas, AnestheticAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810003755916PackageGS150In Commercial Distribution
00810003755919PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081000375591610810003755916
00810003755919008100037559198100037559190810003755919

GMDN Terms#

Term, Definition table
TermDefinition
Resuscitator face mask, single-useA non-sterile, flexible, form-shaped device that is placed over a patient's nose and mouth to direct ambient air, or medical oxygen (O2) and air, from a resuscitator to the upper airway and lungs. It is typically made of non-conductive sterilizable materials (e.g., silicone) that will create a gastight seal against the face. It will typically include a 15 mm and/or 22 mm connector and is available in a range of sizes (baby to adult). It will be directly attached to the resuscitator and held in place on the patient's face by the operator. This device is intended for use with a breathing resuscitator but may be used for the delivery of anaesthesia gases. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
615-384-0573KENTRON@KENTRONMEDICAL.COM

Regulatory Flags#

DUNS number
618825723
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810003755896KENOREX3811002026-05-18
00810003755902KENOREX3811102026-05-18
00810003755926KENOREX3811302026-05-18
00810003755933KENOREX3811402026-05-18
00810003755940KENOREX3811502026-05-18
00810003755957KENOREX8877102026-05-18
00810003752000KENOREX3935062026-05-17
00810003752017KENOREX3935082026-05-17
00810003752024KENOREX3935102026-05-17
00810003752031KENOREX3935122026-05-17
00810003752048KENOREX3935142026-05-17
00810003752055KENOREX3935162026-05-17
00810003752062KENOREX3935182026-05-17
00810003752109KENOREX8800752026-05-17
00810003752154KENOREX8800132026-05-17
00810003752161KENOREX8801132026-05-17
00810003752901KENOREX8801222026-05-17
00810003752994KENOREX8807522026-05-17
00810003753083KENOREX8801782026-05-17
00810003755391KENOREX880225C2026-05-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10192253071443CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
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