FDA.reportPublic FDA data

Flents

Primary DI
00025715696423
Brand
Flents
Company
APOTHECARY PRODUCTS, LLC
Model
69642
Device description
CPR MICROSHIELD 2/24
Published
2020-09-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAEAirway, Oropharyngeal, Anesthesiology

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K871403000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K871403000MODIFIED C.P.R. MICROSHIELDWestmark Enterprises, Inc.1987-05-04CAE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10025715696420PackageGS112In Commercial Distribution
20025715696427PackageGS12In Commercial Distribution
00025715696423PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1002571569642010025715696420
2002571569642720025715696427
00025715696423000257156964230257156964230025715696423

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary resuscitation mask, single-use"A flexible, form-shaped device that is placed over a patient's mouth to administer ""mouth-to-mask"" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace ""mouth-to-mouth"" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS) or as part of first aid kits. This is a single-use device."

Contacts#

Phone, Email table
PhoneEmail
952-890-1940UDI@APOTHECARYPRODUCTS.COM

Regulatory Flags#

DUNS number
092312735
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00025715688404Flents68840/HK688402020-10-28
00079573101988Acu-Life (HE)400198/400198A/HK400198/HK400198A2020-07-31
00079573108512CORE VALUES4008512020-08-31
00031046605065Ezy Dose Self-Care69797/697982021-03-26
00079573104361Acu-Life (HE)400436/400436A2020-09-10
00023185056051FLENTSF405-6052019-01-09
00025715010441FLENTSF405-6042016-09-06
00041520874825Care OneF405-605CO12019-01-09
00023185006032FLENTSF405-6032016-09-06
00025715673585FLENTS673582016-09-06
00025715848150FLENTS848152016-09-06
10025715673582FLENTS673582016-09-06
10025715848157FLENTS848152016-09-06
00023185056204FLENTSF405-6202016-09-06
00025715669502Diabetic Specialty Solutions66949/66949AZ2020-09-10
00025715690025FLENTS654002016-09-06
00840986020131CDCF405-620CD2017-03-06
00681131161756Walmart69002WM2017-01-20
00025715014401EZY DOSE71091BLAMT2022-08-01
00025715014432EZY DOSE71091GAMT2022-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06920687314020INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314037INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314044INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314051INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314068INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314075INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314082INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314099INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314105INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314112INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314129INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314136INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314143INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314150INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314167INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314174INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314181INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314198INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314204INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314211INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314228INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314235INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314242INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314259INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314303INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314310INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314327INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314334INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06946430427632CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2026-08-08
05060112310058LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-08-03