ook cocoon FL36

GUDID 10670482000941

The ook cocoon is an AC-powered medical bed.

Umano Medical Inc

Basic electric hospital bed
Primary Device ID10670482000941
NIH Device Record Keyd791cc40-77af-4296-9de1-e69310745873
Commercial Distribution StatusIn Commercial Distribution
Brand Nameook cocoon
Version Model NumberFL36 ook cocoon
Catalog NumberFL36
Company DUNS249675476
Company NameUmano Medical Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
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

Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100670482000944 [Primary]
GS110670482000941 [Package]
Contains: 00670482000944
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-26
Device Publish Date2025-05-16

On-Brand Devices [ook cocoon]

00670482000111The ook cocoon is an AC-powered medical bed with 4 built-in electric DC actuators.
10670482000071The ook cocoon is an AC-powered medical bed with 4 built-in electric DC actuators. The height an
16704820000073The ook cocoon is an AC-powered medical bed with 4 built-in electric DC actuators. The height an
00670482000203The ook cocoon is an AC-powered medical bed with a SWL of 600lb.
10670482000521The ook cocoon is an AC-powered medical bed with a SWL of 600lb and 15 years service life.
00670482000616The ook cocoon is an AC-powered medical bed with a SWL of 600lb.
10670482000941The ook cocoon is an AC-powered medical bed.

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.