FDA.reportPublic FDA data

aScope™ 5 Broncho HD 5.0/2.2

Primary DI
05707480156306
Brand
aScope™ 5 Broncho HD 5.0/2.2
Company
Ambu A/S
Model
621001000US
Catalog number
621001000US
Device description
Flexible Endoscope
Published
2022-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EOQBronchoscope (flexible or rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05707480156313PackageGS15In Commercial Distribution
05707480156320PackageGS14In Commercial Distribution
05707480156306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05707480156313057074801563135707480156313
05707480156320057074801563205707480156320
05707480156306057074801563065707480156306

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video bronchoscope, single-useAn endoscope with a flexible inserted portion intended for endoscopic procedures of the airways and tracheobronchial tree (i.e., bronchoscopy). It typically consists of a handle portion and an insertion tube which includes working channels and a distal camera from which anatomical images are transmitted and displayed on a monitor (video bronchoscopy). It is typically intended for flexible optical intubation, airway inspection, and may be used to assist in other diagnostic or therapeutic procedures [e.g., bronchoalveolar lavage (BAL)]. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
305682023
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
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
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
05707480024551Ambu® Perfit Collar™0002642050002642052022-12-08

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