BESMED HEALTH BUSINESS CORP.

Address:No. 5, Lane 116, Wu-Kong 2nd Rd. Wu-ku District,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

Monitor, Airway Pressure (Includes Gauge And/Or Alarm) (CAP) (6) Attachment, Breathing, Positive End Expiratory Pressure (BYE) (4)

Premarket Exempt

No Yes

Clear

DURABLE PEEP VALVE 2-10cmH2O, ORANGE, ID:15mm - 04716770213354 Catalog Number :

Device Class : 2

Duns Number: 658023775

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

DURABLE PEEP VALVE 5-20cmH2O, BLUE, ID:30mm - 04716770213408 Catalog Number :

Device Class : 2

Duns Number: 658023775

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

DURABLE PEEP VALVE 5-20cmH2O, BLUE, ID:15mm - 04716770213453 Catalog Number :

Device Class : 2

Duns Number: 658023775

Premarket Exempt : No

Product Code : BYE

Prescription Use : No

Device Count : 1

RESUSCITATOR MANOMETER POP OFF 60cmH2O(PC) - 04716770214504 Catalog Number :

Device Class : 2

Duns Number: 658023775

Premarket Exempt : No

Product Code : CAP

Prescription Use : Yes

Device Count : 1

RESUSCITATOR MANOMETER POP OFF CHILD - 04716770214542 Catalog Number :

Device Class : 2

Duns Number: 658023775

Premarket Exempt : No

Product Code : CAP

Prescription Use : Yes

Device Count : 1

RESUSCITATOR MANOMETER POP OFF ADULT - 04716770214566 Catalog Number :

Device Class : 2

Duns Number: 658023775

Premarket Exempt : No

Product Code : CAP

Prescription Use : Yes

Device Count : 1

RESUSCITATOR MANOMETER POP OFF 60cmH2O(PC) - 04716770214603 Catalog Number :

Device Class : 2

Duns Number: 658023775

Premarket Exempt : No

Product Code : CAP

Prescription Use : Yes

Device Count : 1

RESUSCITATOR MANOMETER POP OFF CHILD - 04716770214641 Catalog Number :

Device Class : 2

Duns Number: 658023775

Premarket Exempt : No

Product Code : CAP

Prescription Use : Yes

Device Count : 1

RESUSCITATOR MANOMETER POP OFF ADULT - 04716770214665 Catalog Number :

Device Class : 2

Duns Number: 658023775

Premarket Exempt : No

Product Code : CAP

Prescription Use : Yes

Device Count : 1

Non-Rebreathing Valve with Manometer Port (L Type) - 04716770217307 Catalog Number :

Device Description : Non-Rebreathing Valve with Manometer Port (L Type)

Device Class : 2

Duns Number: 658023775

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

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