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) (5) Nebulizer (Direct Patient Interface) (CAF) (3) Mask, Oxygen, Low Concentration, Venturi (BYF) (2)

Premarket Exempt

No Yes

Clear

HEADSTAR - 04711402231324 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 PC 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 - 04711402231331 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 PC 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 - 04711402231348 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 PC 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

HEADSTAR - 04711402233014 Catalog Number :

Device Description : VENTURI MASK KIT - ADULTADULT NEBULIZER MASK with 6 DILUTERS, HOOD AND OXYGEN TU VENTURI MASK KIT - ADULTADULT NEBULIZER MASK with 6 DILUTERS, HOOD AND OXYGEN TUBING (7FT)Package: 50 PCS in CS

Device Class : 1

Duns Number: 658122049

Premarket Exempt : Yes

Product Code : BYF

Prescription Use : Yes

Device Count : 1

HEADSTAR - 04711402233021 Catalog Number :

Device Description : VENTURI MASK KIT - CHILDCHILD NEBULIZER MASK with 6 DILUTERS, HOOD AND OXYGEN TU VENTURI MASK KIT - CHILDCHILD NEBULIZER MASK with 6 DILUTERS, HOOD AND OXYGEN TUBING (7FT)Package: 50 PCS in CS

Device Class : 1

Duns Number: 658122049

Premarket Exempt : Yes

Product Code : BYF

Prescription Use : Yes

Device Count : 1

HEADSTAR - 04711402233052 Catalog Number :

Device Description : Headstar Tracheotomy mask comes in adult sizes and is designed to deliver oxygen Headstar Tracheotomy mask comes in adult sizes and is designed to deliver oxygen and humidity to Tracheotomy patient.HP-8508 Adult Tracheotomy Mask (connector ID: 18mm / OD:22mm)

Device Class : 1

Duns Number: 658122049

Premarket Exempt : Yes

Product Code : BYG

Prescription Use : No

Device Count : 1

HEADSTAR - 04711402233069 Catalog Number :

Device Description : Headstar Tracheotomy mask comes in Child sizes and is designed to deliver oxygen Headstar Tracheotomy mask comes in Child sizes and is designed to deliver oxygen and humidity to Tracheotomy patient.HP-8509 Child Tracheotomy Mask (connector ID: 18mm / OD:22mm)

Device Class : 1

Duns Number: 658122049

Premarket Exempt : Yes

Product Code : BYG

Prescription Use : No

Device Count : 1

HEADSTAR - 04711402234158 Catalog Number :

Device Description : HP-2557 Nebulizer Kit(Adult) includes: nebulizer bottle x 1pc, nebulizer mask(ad HP-2557 Nebulizer Kit(Adult) includes: nebulizer bottle x 1pc, nebulizer mask(adult) x 1pc, oxygen tube(HP-1108-7E-B, universal nut & standard connector) x 1 pc

Device Class : 2

Duns Number: 658122049

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

HEADSTAR - 04711402234165 Catalog Number :

Device Description : HP-2558 Nebulizer Kit(Child) includes: nebulizer bottle x 1pc, nebulizer mask(ch HP-2558 Nebulizer Kit(Child) includes: nebulizer bottle x 1pc, nebulizer mask(child) x 1pc, oxygen tube(HP-1108-7E-B, universal nut & standard connector) x 1 pc

Device Class : 2

Duns Number: 658122049

Premarket Exempt : Yes

Product Code : CAF

Prescription Use : Yes

Device Count : 1

HEADSTAR - 04711402234219 Catalog Number :

Device Description : HP-2557 Nebulizer Kit (Child) includes: nebulizer bottle x 1pc, nebulizer mask ( HP-2557 Nebulizer Kit (Child) includes: nebulizer bottle x 1pc, nebulizer mask (child), oxygen tube x 1pc.

Device Class : 2

Duns Number: 658122049

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

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