FDA.reportPublic FDA data

aBox Duodeno

Primary DI
05707480145362
Brand
aBox Duodeno
Company
Ambu A/S
Model
485001000US
Catalog number
485001000US
Device description
aBox Duodeno
Published
2020-08-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDTDuodenoscope and accessories, flexible/rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDTDuodenoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201098000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201098000Ambu Duodeno SystemAmbu Innovation GmbH2020-07-17FDT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05707480145362PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05707480145362057074801453625707480145362

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image processing unitAn electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure80 KiloPascal109 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature-5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure80 KiloPascal109 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+14107686464Purchase_orders@ambuUSA.com
+1(410)768-6464Purchase_orders@ambuUSA.com

Regulatory Flags#

DUNS number
305682023
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05707480167579Ambu® Neuroline Monopolar74225-36/4074225-36/402026-09-05
05707480167593Ambu® Neuroline Monopolar74225-36/4074225-36/402026-09-05
05707480167609Ambu® Neuroline Monopolar74238-36/4074238-36/402026-09-05
05707480167630Ambu® Neuroline Monopolar74325-36/4074325-36/402026-09-05
05707480167661Ambu® Neuroline Monopolar74338-36/4074338-36/402026-09-05
05707480145287aScope™ Duodeno4820010004820010002020-08-10
05707480157402aScope™ Duodeno482001000/4482001000/42022-04-19
05707480136032Isiris™ MonitorMN0001MN00012018-07-30
05707480156306aScope™ 5 Broncho HD 5.0/2.2621001000US621001000US2022-08-19
05707480156337aScope™ 5 Broncho HD 5.6/2.8622001000US622001000US2022-08-19
05707480157259aScope™ 5 Broncho 4.2/2.2620001000US620001000US2023-08-25
05707480157280aScope™ 5 Broncho 2.7/1.2624001000US624001000US2023-08-25
05060038511034Ambu® WhiteSensor 4055440554405542026-08-07
05707480024650Ambu® Mini Perfit ACE™0002811060002811062022-12-08
05707480024674Ambu® Immobilization Kit, with0002811610002811612022-12-08
05707480026197BlueSensor NEOXECG ElectrodesNEOX-60-K/US/3NEOX-60-K/US/32016-09-21
05707480024513Ambu® Perfit Collar™0002642010002642012022-12-08
05707480024520Ambu® Perfit Collar™0002642020002642022022-12-08
05707480024537Ambu® Perfit Collar™0002642030002642032022-12-08
05707480024544Ambu® Perfit Collar™0002642040002642042022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826921391PENTAX MedicalPENTAX MEDICAL CORPORATIONFDT2026-08-25
04580826921407PENTAX MedicalPENTAX MEDICAL CORPORATIONFDT2026-08-25
04580826921438PENTAX MedicalPENTAX MEDICAL CORPORATIONFDT2026-08-25
04580826926693PENTAX MedicalPENTAX MEDICAL CORPORATIONFDT2026-08-25
04580826926709PENTAX MedicalPENTAX MEDICAL CORPORATIONFDT2026-08-25
04580826926778PENTAX MedicalPENTAX MEDICAL CORPORATIONFDT2026-08-25
04580826926792PENTAX MedicalPENTAX MEDICAL CORPORATIONFDT2026-08-25
04580826928406PENTAX MedicalPENTAX MEDICAL CORPORATIONFDT2026-08-25
04580826928499PENTAX MedicalPENTAX MEDICAL CORPORATIONFDT2026-08-25
04580826930935INSPIRAPENTAX MEDICAL CORPORATIONFDT2026-08-25
04580826930959INSPIRAPENTAX MEDICAL CORPORATIONFDT2026-08-25
04953170467370SINGLE USE DISTAL COVEROLYMPUS MEDICAL SYSTEMS CORP.FDT2026-03-06
14953170467377SINGLE USE DISTAL COVEROLYMPUS MEDICAL SYSTEMS CORP.FDT2026-03-06
04961333255801INSPIRAHOYA CORPORATIONFDT2025-06-20
04961333255825INSPIRAHOYA CORPORATIONFDT2025-06-20
05707480157167Ambu® aScope™ Duodeno 2Ambu A/SFDT2025-03-29
04961333356355PENTAX MedicalHOYA CORPORATIONFDT2024-09-03
04961333356331PENTAX MedicalHOYA CORPORATIONFDT2024-09-03
05707480157143Ambu® aScope™ Duodeno 2Ambu A/SFDT2024-07-19
05707480157136Ambu® aScope™ Duodeno 2Ambu A/SFDT2024-07-19
04961333254910INSPIRAHOYA CORPORATIONFDT2023-12-01
04961333247974INSPIRAHOYA CORPORATIONFDT2023-09-16
14961333232960PENTAX MedicalHOYA CORPORATIONFDT2023-07-31
14961333232991PENTAX MedicalHOYA CORPORATIONFDT2023-07-31
14961333246233PENTAX MedicalHOYA CORPORATIONFDT2023-07-31
04961333084456PENTAXHOYA CORPORATIONFDT2023-07-31
04961333084470PENTAXHOYA CORPORATIONFDT2023-07-31
04961333232963PENTAX MedicalHOYA CORPORATIONFDT2023-07-31
04961333232994PENTAX MedicalHOYA CORPORATIONFDT2023-07-31
04961333246236PENTAX MedicalHOYA CORPORATIONFDT2023-07-31