aBox Duodeno 485001000US

GUDID 05707480145362

aBox Duodeno

Ambu A/S

Endoscopic video image processing unit
Primary Device ID05707480145362
NIH Device Record Key9c2a4cfd-6c3d-4ff2-bd84-09380d7e8e84
Commercial Distribution StatusIn Commercial Distribution
Brand NameaBox Duodeno
Version Model Number485001000US
Catalog Number485001000US
Company DUNS305682023
Company NameAmbu A/S
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com

Operating and Storage Conditions

Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 109 KiloPascal
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 109 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 109 KiloPascal
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 109 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 109 KiloPascal
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 109 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 109 KiloPascal
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 109 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 109 KiloPascal
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 109 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 109 KiloPascal
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 109 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 109 KiloPascal
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 109 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 109 KiloPascal
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 109 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 109 KiloPascal
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 109 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 109 KiloPascal
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 109 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 109 KiloPascal
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 109 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 109 KiloPascal
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 109 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 109 KiloPascal
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 109 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 109 KiloPascal
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 109 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105707480145362 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FDTDuodenoscope and accessories, flexible/rigid

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-18
Device Publish Date2020-08-10

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05707480038626 - Immobilization Kit, with2024-07-22 Ambu® Military Perfit ACE™ and Ambu® Military Head Wedge™, Adult
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