FDA.reportPublic FDA data

ook cocoon

Primary DI
10670482000521
Brand
ook cocoon
Company
Umano Medical Inc
Model
FL36 ook cocoon
Catalog number
FL36
Device description
The ook cocoon is an AC-powered medical bed with a SWL of 600lb and 15 years service life.
Published
2021-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

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
10670482000521PackageGS11In Commercial Distribution
00670482000524PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1067048200052110670482000521
00670482000524006704820005246704820005240670482000524

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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