FDA.reportPublic FDA data

ook snow MH

Primary DI
16704820000097
Brand
ook snow MH
Company
Umano Medical Inc
Model
FL36 ook snow MH
Catalog number
FL36
Device description
The ook snow MH, designed for mental health environment, is an AC-powered medical bed with 4 built-in electric DC actuators. The height and surface contours are adjustable.
Published
2016-11-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FNLBed, Ac-Powered Adjustable Hospital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNLBed, Ac-Powered Adjustable HospitalGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26704820000094PackageGS11Not in Commercial Distribution
16704820000097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2670482000009426704820000094
1670482000009716704820000097

GMDN Terms#

Term, Definition table
TermDefinition
Basic electric hospital bedA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
249675476
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00670482001019oneNEST M303-M803508HS2FB-BIL2026-04-24
00670482001026oneNEST M303-M843508HS2FB-BIL2026-04-24
00670482001071Echo-Flex 5002903-00002026-02-18
00670482000982Umano Connect282-0002282-00022025-08-04
00670482000920ook snowFL36 ook snowFL362025-05-16
00670482000944ook cocoonFL36 ook cocoonFL362025-05-16
00670482000951ook snow ALL200-0000200-00002025-05-16
10670482000927ook snowFL36 ook snowFL362025-05-16
00670482000937ook snow MHFL36 ook snow MHFL36 ook snow MH2025-05-16
10670482000941ook cocoonFL36 ook cocoonFL362025-05-16
10670482000958ook snow ALL200-0000200-00002025-05-16
00670482000463Freedom 500FM500FM5002021-02-05
00670482000487Freedom 1000FM1000FM10002021-06-04
00670482000470Freedom 1000FM1000FM10002021-02-05
00670482000838Patient Helper 299-0100WG-TRI299-0100WG-TRI2024-09-17
00670482000845REMOVABLE PATIENT CONTROL – 2 FUNCTIONSFA64511-TRIFA64511-TRI2024-09-17
00670482000852REMOVABLE PATIENT CONTROL – 2 FUNCTIONSFA64509-TRIFA64509-TRI2024-09-17
00670482000869REMOVABLE PATIENT CONTROL – 5 FUNCTIONS299-0152-TRI299-0152-TRI2024-09-17
00670482000876REMOVABLE PATIENT CONTROL – 5 FUNCTIONSFA64510-TRIFA64510-TRI2024-09-17
00670482000883REMOVABLE PATIENT CONTROL – 6 FUNCTIONS299-0151-TRI299-0151-TRI2024-09-17

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Primary DI, Brand, Company table
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