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, Flotation Therapy, Powered (IOQ) (4) Mattress, Air Flotation, Alternating Pressure (FNM) (4) Bed, Ac-Powered Adjustable Hospital (FNL) (2)

Premarket Exempt

Yes

Clear

ook snow ALL - 00670482000227 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 patient sleep surface can be manually extended of 4” with the integrated bed length extender and reach 84” or 88” long. The surface 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, fixed or foldable IV pole, patient helper, oxygen bottle holder and length extension cushions.

Device Class :

Duns Number: 249675476

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

ook snow MH - 00670482000234 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.

Device Class :

Duns Number: 249675476

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

coverNEST gray - 00670482000241 Catalog Number : USTCGS-803607XN-BIL

Device Description : LAL Cover System

Device Class : 2

Duns Number: 249675476

Premarket Exempt : Yes

Product Code : IOQ

Prescription Use : No

Device Count : 1

coverNEST gray - 00670482000258 Catalog Number :

Device Description : LAL Cover System

Device Class : 2

Duns Number: 249675476

Premarket Exempt : Yes

Product Code : IOQ

Prescription Use : No

Device Count : 1

coverNEST gray - 00670482000265 Catalog Number :

Device Description : LAL Cover System

Device Class : 2

Duns Number: 249675476

Premarket Exempt : Yes

Product Code : IOQ

Prescription Use : No

Device Count : 1

coverNEST gray - 00670482000272 Catalog Number : USTCGS-843607XD-BIL

Device Description : LAL Cover System

Device Class : 2

Duns Number: 249675476

Premarket Exempt : Yes

Product Code : IOQ

Prescription Use : No

Device Count : 1

airNEST orange - 00670482000289 Catalog Number :

Device Description : Air Mattress System 80"x35" w. nylon cover

Device Class : 2

Duns Number: 249675476

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

airNEST orange - 00670482000296 Catalog Number :

Device Description : Air Mattress System 80"x35" w. nylon cover and CT plate sleeve.

Device Class : 2

Duns Number: 249675476

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

airNEST orange - 00670482000302 Catalog Number :

Device Description : Air Mattress System 80"x35" w. polyurethane cover

Device Class : 2

Duns Number: 249675476

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

airNEST orange - 00670482000319 Catalog Number :

Device Description : Air Mattress System 80"x35" w. polyurethane cover and CT plate sleeve.

Device Class : 2

Duns Number: 249675476

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

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