FDA.report

aScope™ 4 RhinoLaryngo Slim

Primary DI
05707480140640
Brand
aScope™ 4 RhinoLaryngo Slim
Company
Ambu A/S
Model
510001000
Catalog number
510001000
Device description
Ambu aScope 4 RhinoLaryngo Slim Single-use, flexible Rhinolaryngoscope Sterile from package. Insertion cord diameter 3.0 mm, lenght of 300 mm. and a 130-degree bending angle. Minimum purchase 5 pcs = 1 box
Published
2019-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EOBNasopharyngoscope (flexible or rigid)

Product Code Classifications

CodeDeviceSpecialtyClass
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05707480140640PackageGS14In Commercial Distribution
05707480140657PackageGS15In Commercial Distribution
05707480140664PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05707480140640057074801406405707480140640
05707480140657057074801406575707480140657
05707480140664057074801406645707480140664

GMDN Terms

TermDefinition
Flexible video rhinolaryngoscope, single-useAn endoscope with a flexible inserted portion intended for the visual examination of the upper airway structures which include the nasal passages, nasopharynx, oropharynx, and the larynx. It is inserted into the body through the mouth or a nostril and can be used for treatment if it has a working channel. Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end of the endoscope and the images showing on a monitor. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Length300Millimeter
Outer Diameter3Millimeter

Storage And Handling

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 Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+14107686464Purchase_orders@ambuUSA.com
+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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05707480006397Perfit Collar™0002642010002642012022-12-08
05707480006403Perfit Collar™0002642020002642022022-12-08
05707480006410Perfit Collar™0002642030002642032022-12-08
05707480006427Perfit Collar™0002642040002642042022-12-08
05707480006434Perfit Collar™0002642050002642052022-12-08
05707480006441Perfit Collar™0002642060002642062022-12-08
05707480006458Perfit Collar™0002645010002645012022-12-08
05707480006465Perfit Collar™0002645020002645022022-12-08
05707480006472Perfit Collar™0002645030002645032022-12-08
05707480006489Perfit Collar™0002645040002645042022-12-08
05707480006496Perfit Collar™0002645050002645052022-12-08
05707480018420Perfit ACE™0002810000002810002022-12-08
05707480018437Military Perfit ACE™000281000MIL000281000MIL2022-12-08
05707480006526Mini Perfit ACE™0002811060002811062022-12-08
05707480025459AuraOnce321100000U321100000U2022-12-08
05707480025473AuraOnce321200000U321200000U2022-12-08
05707480025497AuraOnce321300000U321300000U2022-12-08
05707480025503AuraOnce321400000U321400000U2022-12-08
05707480025435AuraOnce321500000U321500000U2022-12-08
05707480025527AuraOnce321600000U321600000U2022-12-08

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850042909003ProsidioProsidio LLCEOB2026-01-16
00850042909010ProsidioProsidio LLCEOB2026-01-16
00850042909812ProsidioProsidio LLCEOB2026-01-16
00848657076883AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EOB2026-01-15
00848657076890AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EOB2026-01-15
00848657077712AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EOB2026-01-15
00848657078139AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EOB2026-01-15
00848657078146AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EOB2026-01-15
04961333255191VIVIDEOHOYA CORPORATIONEOB2025-12-19
04961333255245VIVIDEOHOYA CORPORATIONEOB2025-12-19
00850042909027ProsidioProsidio LLCEOB2025-12-05
00850042909034ProsidioProsidio LLCEOB2025-12-05
00850042909041ProsidioProsidio LLCEOB2025-12-05
00850042909058ProsidioProsidio LLCEOB2025-12-05
00850042909065ProsidioProsidio LLCEOB2025-12-05
00850042909072ProsidioProsidio LLCEOB2025-12-05
00850042909089ProsidioProsidio LLCEOB2025-12-05
00850042909096ProsidioProsidio LLCEOB2025-12-05
00850042909102ProsidioProsidio LLCEOB2025-12-05
00850042909119ProsidioProsidio LLCEOB2025-12-05
00850042909126ProsidioProsidio LLCEOB2025-12-05
00850042909133ProsidioProsidio LLCEOB2025-12-05
00850042909140ProsidioProsidio LLCEOB2025-12-05
00850042909157ProsidioProsidio LLCEOB2025-12-05
00850042909164ProsidioProsidio LLCEOB2025-12-05
00850042909171ProsidioProsidio LLCEOB2025-12-05
00850042909188ProsidioProsidio LLCEOB2025-12-05
00850042909195ProsidioProsidio LLCEOB2025-12-05
00850042909201ProsidioProsidio LLCEOB2025-12-05
00850042909829ProsidioProsidio LLCEOB2025-12-05