HSINER CO., LTD.

Address:312, Jhongshang Rd., Shengang Dist.,TAICHUNG 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

Set, Tubing And Support, Ventilator (W Harness) (BZO) (5) Cannula, Nasal, Oxygen (CAT) (4) Ventilator, Continuous, Facility Use (CBK) (1)

Premarket Exempt

No Yes

Clear

Hsiner - 04711064681659 Catalog Number : 14932

Device Description : High Flow Nasal Cannula XS

Device Class : 1

Duns Number: 657310868

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : Yes

Device Count : 1

Hsiner - 04711064681666 Catalog Number : 14933

Device Description : High flow nasal cannula, S

Device Class : 1

Duns Number: 657310868

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : No

Device Count : 1

Hsiner - 04711064681673 Catalog Number : 14934

Device Description : High flow nasal cannula, M

Device Class : 1

Duns Number: 657310868

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : No

Device Count : 1

Hsiner - 04711064681680 Catalog Number : 14935

Device Description : High flow nasal cannula, L

Device Class : 1

Duns Number: 657310868

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : No

Device Count : 1

Hsiner - 04711064686753 Catalog Number : VY70136-22F

Device Description : Corrugate Catheter Mount tubing length: 15cm, 22OD/15ID; 22ID

Device Class : 1

Duns Number: 657310868

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : Yes

Device Count : 1

Hsiner - 04711064686760 Catalog Number : VY70134-22F

Device Description : Corrugate Catheter Mount, tubing length: 15cm, 22OD/15ID; 22ID

Device Class : 1

Duns Number: 657310868

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : Yes

Device Count : 1

Hsiner - 04711064686777 Catalog Number : VY70133-22F

Device Description : Collapsible Catheter Mount, tubing length: 15cm, 22OD/15D,22ID, w/sampling port

Device Class : 1

Duns Number: 657310868

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : Yes

Device Count : 1

Hsiner - 04711064686784 Catalog Number : VY70139

Device Description : Corrugate Catheter Mount 18cm, 22OD/15ID; 22IDw/sampling port

Device Class : 1

Duns Number: 657310868

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : Yes

Device Count : 1

Hsiner - 04711064686791 Catalog Number : VY70132-000-22F

Device Description : Catheter Mount W/ collapsible tubing 18cm,22OD/15ID, 22ID

Device Class : 1

Duns Number: 657310868

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : Yes

Device Count : 1

Hsiner - 04712688051286 Catalog Number : 10214

Device Description : NIPPV Silicone Face mask set

Device Class : 2

Duns Number: 657310868

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

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