Umano Medical Inc

Address:230 Boulevard Nilus-Leclerc,L Islet Quebec,CA

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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

Bed, Ac-Powered Adjustable Hospital (FNL) (6) Mattress, Air Flotation, Alternating Pressure (FNM) (4)

Premarket Exempt

Yes

Clear

airNEST orange HYBRID - 00670482000425 Catalog Number :

Device Description : Convertible air/foam Mattress System w. polyurethane cover 84"x35" and CT plate sleeve.

Device Class : 2

Duns Number: 249675476

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

airNEST orangeXi - 00670482000432 Catalog Number :

Device Description : Air Mattress System 80"/84"/88"x36"/42"/48" x 10" w. nylon cover

Device Class : 2

Duns Number: 249675476

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

airNEST orangeXi - 00670482000449 Catalog Number :

Device Description : Air Mattress System 80"/84"/88"x36"/42"/48" x 10" w. polyurethane cover

Device Class : 2

Duns Number: 249675476

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

airNEST orange - 00670482000456 Catalog Number :

Device Description : Air Mattress System 84"x35" w. polyurethane cover

Device Class : 2

Duns Number: 249675476

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Freedom 500 - 00670482000463 Catalog Number : FM500

Device Description : Medical bed.

Device Class : 2

Duns Number: 249675476

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

Freedom 1000 - 00670482000470 Catalog Number : FM1000

Device Description : Medical bed.

Device Class :

Duns Number: 249675476

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

Freedom 1000 - 00670482000487 Catalog Number : FM1000

Device Description : AC-powered medical bed.

Device Class : 2

Duns Number: 249675476

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

ook snow ALL - 00670482000494 Catalog Number : 200-0000

Device Description : AC-powered medical bed with 4 built-in electric DC actuators that offers a power AC-powered medical bed with 4 built-in electric DC actuators that offers a powered adjustment of the height and surface contours. Bed includes movable and latchable siderails or patient mobilization helper, and control boards. The deck can be manually extended of 4” with the integrated bed length extender and reach 84” or 88” long. The deck width can be manually extended from 35” up to 47”. The product offers a range of options and accessories including but not limited to integrated scale, integrated bed exit system, bed status monitoring, Pilot Drive, fixed or foldable IV pole, patient helper, oxygen bottle holder and length extension cushions.

Device Class : 2

Duns Number: 249675476

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

ook snow - 00670482000500 Catalog Number : FL36

Device Description : The ook snow is an AC-powered medical bed that offers an optional bed status mon The ook snow is an AC-powered medical bed that offers an optional bed status monitoring system. The bed maximum safe working load is of 600lb and a service life of 15 years.

Device Class : 2

Duns Number: 249675476

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

ook snow MH - 00670482000517 Catalog Number : FL36

Device Description : The ook snow MH, model FL36, is an AC-powered medical bed with 4 built-in electr The ook snow MH, model FL36, is an AC-powered medical bed with 4 built-in electric DC actuators and controls that is intended for medical purposes in mental health care units and/or environments. The maximum safe working load of the bed is of 600lb and a service life of 15 years.

Device Class : 2

Duns Number: 249675476

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

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