FDA.reportPublic FDA data

HEADSTAR

Primary DI
04711402231331
Brand
HEADSTAR
Company
HEADSTAR MEDICAL PRODUCTS CO., LTD.
Model
HS-8804P
Device description
Headstar 100% latex-free face masks come in a wide variety of sizes and materials to suit the patient's needs. #4 Silicone mask with PC dome for Small AdultHeadstar offers anatomically designed face mask that brings maximum comfort to the patient.
Published
2020-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Product Codes#

Code, Name table
CodeName
BYGMask, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04711402231331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04711402231331047114022313314711402231331

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."

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
658122049
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04711402237128HEADSTARHP-80002025-10-13
04711402237012HEADSTARHP-80402025-10-08
04711402237029HEADSTARHP-80502025-10-08
04711402237036HEADSTARHP-80602025-10-08
04711402237043HEADSTARHP-80702025-10-08
04711402237050HEADSTARHP-80802025-10-08
04711402237067HEADSTARHP-80902025-10-08
04711402237074HEADSTARHP-81002025-10-08
04711402237081HEADSTARHP-81102025-10-08
04711402235056HEADSTARHP-1108-7E2020-03-26
04711402233052HEADSTARHP-85082021-03-25
04711402233069HEADSTARHP-85092021-03-25
04711402231263HEADSTARHS-88002020-05-27
04711402231270HEADSTARHS-88012020-05-27
04711402231287HEADSTARHS-88022020-05-27
04711402231294HEADSTARHS-88032020-05-27
04711402231300HEADSTARHS-88042020-05-27
04711402231317HEADSTARHS-88052020-05-27
04711402231324HEADSTARHS-8803P2020-05-27
04711402231348HEADSTARHS-8805P2020-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04816415501379LARYNGEAL MASK Single Use Size 2ASSOMEDIKA, OOOBYG2026-05-27
04816415501386LARYNGEAL MASK Single Use Size 3ASSOMEDIKA, OOOBYG2026-05-27
04816415501393LARYNGEAL MASK Single Use Size 5ASSOMEDIKA, OOOBYG2026-05-27
08697645018129ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018136ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018143ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
09420012427632Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBYG2026-03-18
09420012428585Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBYG2026-03-18
10885632467400HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10885632467417HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10885632467462HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10889483221662Performance Home MedicalSUNMED, LLCBYG2025-12-31
10889483227268BiFLo™SUNMED, LLCBYG2025-12-30
10889483227275BiFLo™SUNMED, LLCBYG2025-12-30
10889483223970AirLife™SUNMED, LLCBYG2025-12-19
10889483224151AirLife™SUNMED, LLCBYG2025-12-19
10889483224298DeVilbissSUNMED, LLCBYG2025-12-19
10889483224687AirLife™SUNMED, LLCBYG2025-12-19
10889483224168AirLife™SUNMED, LLCBYG2025-12-18
10197344011117HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011742HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011759HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011773HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344042203HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011582HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344011599HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344011605HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344011612HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344009626HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-06
10197344010646HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-06