FDA.reportPublic FDA data

KEMP USA

Primary DI
04719871897911
Brand
KEMP USA
Company
FOREMOUNT ENTERPRISE CO., LTD.
Model
10-526
Device description
CPR MASK COMO ADULT AND CHILD SOFT POUCH
Published
2026-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CBPValve, Non-Rebreathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBPValve, Non-RebreathingAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719871897911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719871897911047198718979114719871897911

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.

Regulatory Flags#

DUNS number
658718465
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719871896730Aero US1FAXX-00772026-02-12
04719871896747Aero US1FAXX-01012026-02-12
04719871896754Aero US1FAXX-01182026-02-12
04719871896761Aero US1FCXX-00242026-02-12
04719871896778Aero US1FCXX-00262026-02-12
04719871896785Aero US1FDXX-00312026-02-12
04719871896792Aero US1FM4A-00252026-02-12
04719871896808Aero US1FM4A-00352026-02-12
04719871897874KEMP USA10-5012026-02-12
04719871897881KEMP USA10-501-SE2026-02-12
04719871897898KEMP USA10-5252026-02-12
04719871897904KEMP USA10-525-NL2026-02-12
04719871897928KEMP USA10-5142026-02-12
04719871897935Code One1FAXX-00162026-02-12
04719871897942Code One1FAXX-01092026-02-12
04719871892251JBC400-1046/252024-07-18
04719871890011WNLME6201B-FAK5000GIRED2024-06-28
04719871890028WNLME6201NB2-FAK5000SGI2024-06-28
04719871890042WNLME6201NB12-FAK5000SG2024-06-28
04719871890059WNLME6201-FAK5000G-RED2024-06-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B448260103XpectFirstar Healthcare Company Limited (Guangzhou)CBP2026-05-13
10889483570562AirLife™AIRLIFECBP2025-03-28
B0023000X0RescuerB.L.S. Systems LimitedCBP2023-12-11
09420012445261Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCBP2023-07-06
00634376498507(HEALTH & SAFETY INSTITUDE) HSI CPR REDI-SHIELD (Made in USA) with key ring caseRONDEX PRODUCTS, INCORPORATEDCBP2023-01-02
00634376498576(HEALTH & SAFETY INSTITUTE) HSI CPR REDI-SHIELD with keyring case & gloves RONDEX PRODUCTS, INCORPORATEDCBP2023-01-02
0076658801349724M - Tampa Electric Co.Certified Safety Manufacturing, Inc.CBP2022-07-15
0076658802201724M - Salt River Project-21 - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588030111XLP - Toyota - Black - XLPouchCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588049045HSB - BBP - Southern Co.Certified Safety Manufacturing, Inc.CBP2022-07-15
0076658806057625M - First Aid Kit - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658806123824PW - Turtle Top Florida DOT - Poly WhiteCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588070650EMT Trauma Care - Red Cordovia BagCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658808074136M - Enbridge - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658809053510PC - Rail America Locomotive - PolyCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588090610Emergency Trauma Care Deluxe - Orange Co-Polymer CaseCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588100029Sports Bag - Fanny PackCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658810093710PW - Head Start - Poly WhiteCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588107042SB-2 - Head Start - Fanny PackCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658810957210M - Sempra - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658811012710PC - UP - 380-54620 - LocamotiveCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812001010M - State of South Dakota DOT BBP - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812068310PW - Hawaiian TelecomCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812072018PR - First Aid Complete Kit - Poly RedCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812082916PW - PCI Construction - Poly WhiteCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588121079FAC-4 - Miller & Long ConcreteCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812966275V - UP Facilities - RefillCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658813049136M - PacifiCorp - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658813058316PW - Los Alamos - Poly WhiteCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658814080310PW - RJ Corman - Poly WhiteCertified Safety Manufacturing, Inc.CBP2022-07-15