FDA.reportPublic FDA data

Ambu® aScope™ Duodeno 2

Primary DI
05707480157143
Brand
Ambu® aScope™ Duodeno 2
Company
Ambu A/S
Model
486104000
Catalog number
486104000
Device description
Duodenoscope
Published
2024-07-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05707480157136PackageGS14In Commercial Distribution
05707480157143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05707480157136057074801571365707480157136
05707480157143057074801571435707480157143

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video duodenoscope, single-useAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the duodenum (the first part of the small intestine). It is inserted into the body through the mouth during duodenoscopy. Anatomical images are transmitted to the user by a video system with a complementary metal oxide semiconductor (CMOS) chip at the distal end of the endoscope and the images showing on a monitor. This device is commonly used to examine structures and mucous membranes of the duodenum for conditions like ulcers, polyps, and cancer. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1240Millimeter
Lumen/Inner Diameter4.2Millimeter
Outer Diameter13.7Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure80 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius25 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
305682023
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
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
04953170438066Air/water valveOLYMPUS MEDICAL SYSTEMS CORP.FDT2023-04-22