aView™ Monitor

DI: 05707480133154 · Model: 405002000 · Ambu A/S

View on AccessGUDID

Product Codes

GMDN Terms

Identifiers

Pkg Device Count

Basic Information

Brand Name: aView™ Monitor
Primary DI: 05707480133154
Version / Model: 405002000
Catalog Number: 405002000
Company Name: Ambu A/S
Labeler DUNS: 305682023
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-09-22
Public Version: 6
Public Version Date: 2023-09-13
Public Version Status: Update
Public Device Record Key: c4d15dfc-6ccd-46c7-b7a2-9cedaf15ec47

Device Description

Ambu aView, new updated version. Reusable, portable monitor with touch-screen Compatible with all aScope4 versions, aScope3 versions and VivaSight-DL and SL. With Video-out function and live zoom for a more large and detailed view.

Device Characteristics

Single Use: No
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: Yes
Has Lot/Batch Number: Yes
Has Manufacturing Date: Yes
Has Expiration Date: No
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EOQ	BRONCHOSCOPE (FLEXIBLE OR RIGID)	Ear, Nose, Throat	874.4680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56654	Endoscopic video image display unit	An electrically-powered visual display unit (VDU), commonly known as a screen or a monitor, designed to be used exclusively in conjunction with a video endoscope to display to the operator the graphical information captured by the endoscope to facilitate its manipulation during the endoscopic procedure; typically difficult and non-difficult intubation procedures to maintain an open airway. It is typically a portable device with a liquid crystal display (LCD) colour screen and a direct electronic signal connection to the endoscope.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05707480133154	GS1

Customer Contacts

Phone: +14107686464
Email: [email protected]

Device Sizes

Type	Value	Unit
Height	175	Millimeter
Weight	1500	Gram
Width	241	Millimeter

Storage Conditions

Type: Handling Environment Temperature
Temperature Range: 10 – 40 Degrees Celsius
Type: Handling Environment Atmospheric Pressure
Temperature Range: 80 – 109 KiloPascal
Type: Storage Environment Atmospheric Pressure
Temperature Range: 80 – 109 KiloPascal
Type: Storage Environment Humidity
Temperature Range: 30 – 85 Percent (%) Relative Humidity
Type: Storage Environment Temperature
Temperature Range: 10 – 40 Degrees Celsius
Type: Handling Environment Humidity
Temperature Range: 30 – 85 Percent (%) Relative Humidity