DEVICE: ook snow MH (00670482000135)

Device Identifier (DI) Information

ook snow MH
FL36 ook snow MH
In Commercial Distribution
FL36
Umano Medical Inc
00670482000135
GS1

1
249675476 *Terms of Use
00670482000098
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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Device Characteristics

MR Unsafe
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
34870 Basic electric hospital bed
A mains electricity (AC-powered) bed designed to be used as a patient bed for rest/sleep in a hospital ward/room, and which is motorized providing the patient/nursing staff with touch button adjustment possibilities. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard, siderails, and a remote control to operate the electrical motors. It may have an integrated weighing scale.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FNL Bed, Ac-Powered Adjustable Hospital
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 100 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 158 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

8fc98ba3-86fe-4c36-a7ba-6466c6876a78
March 29, 2018
2
January 10, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10670482000132 1 00670482000135 In Commercial Distribution
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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