FDA.reportPublic FDA data

Xpect

Primary DI
B448260103
Brand
Xpect
Company
Firstar Healthcare Company Limited (Guangzhou)
Model
FS-103
Published
2026-05-13
Public version status
New
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B448260103PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary resuscitation mask, reusable"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). This is a reusable device."

Regulatory Flags#

DUNS number
529576331
Device count
1
Premarket exempt
true
Combination product
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B448A0019990MICRO BIRDA0019992026-02-11
B448A0020040MICRO BIRDA0020042026-02-11
B448FS1040Seal QuikFS-1042025-12-10
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
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
0076658815016136M - Class B BMD - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15