HEADSTAR MEDICAL PRODUCTS CO., LTD.

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

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Filters

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

Airway, Oropharyngeal, Anesthesiology (CAE) (1) Cannula, Nasal, Oxygen (CAT) (1) Nebulizer (Direct Patient Interface) (CAF) (1)

Premarket Exempt

No Yes

Clear

HEADSTAR - 04711402234226 Catalog Number :

Device Description : HP-2558 Nebulizer Kit (Adult) includes: nebulizer bottle x 1pc, nebulizer mask ( HP-2558 Nebulizer Kit (Adult) includes: nebulizer bottle x 1pc, nebulizer mask (adult) x 1pc, oxygen tube x 1pc.

Device Class : 2

Duns Number: 658122049

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

HEADSTAR - 04711402235056 Catalog Number :

Device Description : 7FT OXYGEN TUBING ONE PCS per PE BAG, 250 PCS per CS

Device Class : 1

Duns Number: 658122049

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : No

Device Count : 1

HEADSTAR - 04711402236077 Catalog Number :

Device Description : REUSABLEDIVERTER, AUTOCLAVED TO 121 Degree C ( MATERIAL : PC )Package: 250 PCS p REUSABLEDIVERTER, AUTOCLAVED TO 121 Degree C ( MATERIAL : PC )Package: 250 PCS per PE BAG, 250 PCS in a CS

Device Class : 1

Duns Number: 658122049

Premarket Exempt : Yes

Product Code : CAE

Prescription Use : Yes

Device Count : 1

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