BOMImed Inc

Address:1-100 IRENE STREET,WINNIPEG, Manitoba,CA

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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

Laryngoscope, Rigid (CCW) (2) Filter, Bacterial, Breathing-Circuit (CAH) (1) Stylet, Tracheal Tube (BSR) (1)

Premarket Exempt

No Yes

Clear

INTROES POCKET BOUGIE - 10629160000018 Catalog Number : OL-E12102

Device Description : INTROES POCKET BOUGIE - Endotracheal Tuber Introducer, 14FR (4.7mm) x 60cm

Device Class : 1

Duns Number: 248200149

Premarket Exempt : Yes

Product Code : BSR

Prescription Use : No

Device Count : 1

BOMImed Saver - 10629160000032 Catalog Number : OL-3312

Device Description : BOMImed Disposable Saver Laryngoscope Blade

Device Class : 1

Duns Number: 248200149

Premarket Exempt : Yes

Product Code : CCW

Prescription Use : No

Device Count : 1

BOMImed Saver - 10629160000056 Catalog Number : OL-3314

Device Description : BOMImed Disposable Saver Laryngoscope Blade

Device Class : 1

Duns Number: 248200149

Premarket Exempt : Yes

Product Code : CCW

Prescription Use : No

Device Count : 1

AQUESURE FILTER HUMIDIFIER - 10629160012608 Catalog Number : OL-040419-U00

Device Description : Breathing circuit filter with built-in humidification

Device Class : 2

Duns Number: 248200149

Premarket Exempt : No

Product Code : CAH

Prescription Use : No

Device Count : 1

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