ook snow MH - The ook snow MH is designed for mental health - Umano Medical Inc

Duns Number:249675476

Device Description: The ook snow MH is designed for mental health environment and is an AC-powered medical bed The ook snow MH is designed for mental health environment and is an AC-powered medical bed with 4 built‑in electric DC actuators. The height and surface contours are adjustable. The bed includes movable and latchable siderails, control boards and tamperproof fasteners. The product offers a range of options and accessories outlined in the manuals, including, but not limited to: integrated scale, bed exit system, integrated bed extender, floor fixation and, siderails and boards without openings. The expected life under normal usage and maintenance is 10 years.The ook snow MH is adapted to mental health environment and is designed for use with patients that may have special safety needs, such as patients with mental illness, for procedures, therapy and recovery in adapted health care environments, including, but not limited to, outpatient care, rehabilitation centers and, recovery or therapeutic areas. Some features, such as the adjustable power cord length, are intended for patients with special safety needs. The product can be used for patient transportation between bays and procedural rooms. The overall capacity of the bed goes up to is 600 lb. The bed is designed for the use of one single person and, to be used with a sleep surface. The patient sleep surface can be 80" long or, up to 84" or 90" with an integrated bed extender and cushion. Users are health care providers, which can use all bed operations, patient and bystanders, which can use bed motion functions, and maintenance staff.

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More Product Details

Catalog Number

FL36

Brand Name

ook snow MH

Version/Model Number

FL36 ook snow MH

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FNL

Product Code Name

Bed, Ac-Powered Adjustable Hospital

Device Record Status

Public Device Record Key

8fc98ba3-86fe-4c36-a7ba-6466c6876a78

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 10, 2018

Additional Identifiers

Package DI Number

10670482000132

Quantity per Package

1

Contains DI Package

00670482000135

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"UMANO MEDICAL INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 32