HEADSTAR MEDICAL PRODUCTS CO., LTD.

Address:7F, No. 14, WU-GONG 5th Rd., WU-GU Dist.,NEW TAIPEI CITY,TW

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Mask, Oxygen (BYG) (6) Ventilator, Emergency, Manual (Resuscitator) (BTM) (4)

Premarket Exempt

No Yes

Clear

HEADSTAR - 04711402230280 Catalog Number :

Device Description : SILICONE RESUSCITATOR BAG ADULT With POP OFF (With HS Logo)AUTOCLAVE TO 121 Deg SILICONE RESUSCITATOR BAG ADULT With POP OFF (With HS Logo)AUTOCLAVE TO 121 Degree C MATERIAL : PCONE PC PER BAG, TEN PC PER CTN With INSTRUCTION BOOKLET

Device Class : 2

Duns Number: 658122049

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

HEADSTAR - 04711402230464 Catalog Number :

Device Description : HP93111A-3U Adult PVC Resuscitator Kit, includes:HP-9511A PVC Manual Resuscitat HP93111A-3U Adult PVC Resuscitator Kit, includes:HP-9511A PVC Manual Resuscitator Bag - Adult x 1 pcHP-8405C #5 Air Cushion Mask x 1 pcHP-3308B Single-patient-use Reservoir Valve Set x 1 pcHP-1108 Oxygen Tubing x 1 pc*Package: PE bag/set*

Device Class : 2

Duns Number: 658122049

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

HEADSTAR - 04711402230471 Catalog Number :

Device Description : HP93111C-3U Child PVC Resuscitator Kit, includes:HP-9833A PVC Manual Resuscita HP93111C-3U Child PVC Resuscitator Kit, includes:HP-9833A PVC Manual Resuscitator Bag - Child x 1 pcHP-8403C #3 Air Cushion Mask x 1 pcHP-3308B Single-patient-use Reservoir Valve set x 1 pcHP-1108 Oxygen Tubing x 1 pc*Package: PE bag/set*

Device Class : 2

Duns Number: 658122049

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

HEADSTAR - 04711402230488 Catalog Number :

Device Description : HP93111I-3U Infant PVC Resuscitator Kit, includes:HP-9333A PVC Manual Resuscit HP93111I-3U Infant PVC Resuscitator Kit, includes:HP-9333A PVC Manual Resuscitator Bag - Infant x 1 pcHP-8401C #1 Air Cushion Mask x 1 pcHP-3306B Single-patient-use Reservoir Valve set x 1 pcHP-1108 Oxygen Tubing x 1 pc*Package: PE bag/set*

Device Class : 2

Duns Number: 658122049

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

HEADSTAR - 04711402231263 Catalog Number :

Device Description : Headstar 100% latex-free face masks come in a wide variety of sizes and material Headstar 100% latex-free face masks come in a wide variety of sizes and materials to suit the patient's needs. #0 Silicone mask for small InfantHeadstar offers anatomically designed face mask that brings maximum comfort to the patient.

Device Class : 1

Duns Number: 658122049

Premarket Exempt : Yes

Product Code : BYG

Prescription Use : Yes

Device Count : 1

HEADSTAR - 04711402231270 Catalog Number :

Device Description : Headstar 100% latex-free face masks come in a wide variety of sizes and material Headstar 100% latex-free face masks come in a wide variety of sizes and materials to suit the patient's needs. #1 Silicone mask for Large InfantHeadstar offers anatomically designed face mask that brings maximum comfort to the patient.

Device Class : 1

Duns Number: 658122049

Premarket Exempt : Yes

Product Code : BYG

Prescription Use : Yes

Device Count : 1

HEADSTAR - 04711402231287 Catalog Number :

Device Description : Headstar 100% latex-free face masks come in a wide variety of sizes and material Headstar 100% latex-free face masks come in a wide variety of sizes and materials to suit the patient's needs. #2 Silicone mask for small ChildHeadstar offers anatomically designed face mask that brings maximum comfort to the patient.

Device Class : 1

Duns Number: 658122049

Premarket Exempt : Yes

Product Code : BYG

Prescription Use : Yes

Device Count : 1

HEADSTAR - 04711402231294 Catalog Number :

Device Description : Headstar 100% latex-free face masks come in a wide variety of sizes and material Headstar 100% latex-free face masks come in a wide variety of sizes and materials to suit the patient's needs. #3 Silicone mask with PSF dome for Large ChildHeadstar offers anatomically designed face mask that brings maximum comfort to the patient.

Device Class : 1

Duns Number: 658122049

Premarket Exempt : Yes

Product Code : BYG

Prescription Use : Yes

Device Count : 1

HEADSTAR - 04711402231300 Catalog Number :

Device Description : Headstar 100% latex-free face masks come in a wide variety of sizes and material 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 PSF dome for Small AdultHeadstar offers anatomically designed face mask that brings maximum comfort to the patient.

Device Class : 1

Duns Number: 658122049

Premarket Exempt : Yes

Product Code : BYG

Prescription Use : Yes

Device Count : 1

HEADSTAR - 04711402231317 Catalog Number :

Device Description : Headstar 100% latex-free face masks come in a wide variety of sizes and material Headstar 100% latex-free face masks come in a wide variety of sizes and materials to suit the patient's needs. #5 Silicone mask with PSF dome for Large AdultHeadstar offers anatomically designed face mask that brings maximum comfort to the patient.

Device Class : 1

Duns Number: 658122049

Premarket Exempt : Yes

Product Code : BYG

Prescription Use : Yes

Device Count : 1

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