ook snow MH FL36

GUDID 00670482000135

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.

Umano Medical Inc

Basic electric hospital bed
Primary Device ID00670482000135
NIH Device Record Key8fc98ba3-86fe-4c36-a7ba-6466c6876a78
Commercial Distribution StatusIn Commercial Distribution
Brand Nameook snow MH
Version Model NumberFL36 ook snow MH
Catalog NumberFL36
Company DUNS249675476
Company NameUmano Medical Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100670482000098 [Previous]
GS100670482000135 [Primary]
GS110670482000132 [Package]
Package: [1 Units]
In Commercial Distribution

FDA Product Code

FNLBed, Ac-Powered Adjustable Hospital

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2018-01-10

On-Brand Devices [ook snow MH]

00670482000166The ook snow MH is a Medical bed.
00670482000135The ook snow MH is designed for mental health environment and is an AC-powered medical bed with
00670482000098The ook snow MH, designed for mental health environment, is an AC-powered medical bed with 4 bui
16704820000097The ook snow MH, designed for mental health environment, is an AC-powered medical bed with 4 bui
00670482000197The ook snow MH is an AC-powered Medical bed that offers an optional bed status monitoring syste
00670482000234The ook snow MH, model FL36, is an AC-powered medical bed with 4 built-in electric DC actuators
10670482000514The ook snow MH, model FL36, is an AC-powered medical bed with 4 built-in electric DC actuators
00670482000609The ook snow MH, model FL36, is an AC-powered medical bed with 4 built-in electric DC actuators

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