FDA.report

aScope™ 3 Slim 3.8/1.2Flexible Videoscope - Singl

Primary DI
05707480121977
Brand
aScope™ 3 Slim 3.8/1.2Flexible Videoscope - Singl
Company
Ambu A/S
Model
402001000
Catalog number
402001000
Device description
Ambu aScope 3 Slim - Video Bronchioscope Single-Use, Flexible and Sterile. Insertion cord dia 3.8 mm, channel width of 1.2 mm. Bending angle of 130°/1
Published
2016-09-21
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

Related Records

Contact Domains

Product Codes

CodeName
EOQBRONCHOSCOPE (FLEXIBLE OR RIGID)

Product Code Classifications

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05707480121977PackageGS15In Commercial Distribution
05707480121984PackageGS14In Commercial Distribution
05707480121960PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05707480121977057074801219775707480121977
05707480121984057074801219845707480121984
05707480121960057074801219605707480121960

GMDN Terms

TermDefinition
Flexible video bronchoscope, single-useA sterile 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 commonly intended for flexible optical intubation, airway inspection, and may assist other diagnostic or therapeutic procedures [e.g., bronchoalveolar lavage (BAL)]. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Length600Millimeter
Lumen/Inner Diameter1.2Millimeter
Outer Diameter3.8Millimeter

Storage And Handling

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

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