FDA.reportPublic FDA data

Seal Quik

Primary DI
B448FS1040
Brand
Seal Quik
Company
Firstar Healthcare Company Limited (Guangzhou)
Model
FS-104
Device description
FS-104 CPR MASK
Published
2025-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

Product Codes#

Code, Name table
CodeName
CBPValve, Non-Rebreathing

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083418000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083418000CPR MASKFirstar Healthcare Co., Ltd.2010-07-22CBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B448FS1040PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary resuscitation mask, single-useA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529576331
Device count
1
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
B448260103XpectFS-1032026-05-13
B448A0019990MICRO BIRDA0019992026-02-11
B448A0020040MICRO BIRDA0020042026-02-11
B4484852KITPPE0callington4852/KIT/PPE2025-09-25
B448A0020030MICRO BIRDA00200302025-09-25
B448FA050FirstarFA052025-09-25
B448SQ12120BrightCareSQ12122025-06-19
B448SQ12130BrightCareSQ12132025-06-19
B448SQ12140BrightCareSQ12142025-06-19
B448SQ12150BrightCareSQ12152025-06-19
B448SQ12200BrightCareSQ12202025-06-19
B448SQ12210BrightCareSQ12212025-06-19
B448SQ12220BrightCareSQ12222025-06-19
B448A0019980MICRO BIRDA0019982025-03-24
B448FS90200OuterbanksFS-90202025-02-25
B448FS97310OuterbanksFS-97312025-02-25
B448WCC001Windy City CabinetWCC-0012024-01-24
B44849660FIRSTAR49662023-08-31
B448FS1030E+RFS-1032023-08-31
06942272610300E+RFS-1032022-11-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946430426185GFAXIAMEN COMPOWER MEDICAL TECH. CO., LTDCBP2026-06-01
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
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0076658812072018PR - First Aid Complete Kit - Poly RedCertified Safety Manufacturing, Inc.CBP2022-07-15
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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