AccessGUDID - DEVICE: aView™ Monitor (05707480133154)

GUDID

Device Identifier (DI) Information

Brand Name: aView™ Monitor
Version or Model: 405002000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 405002000
Company Name: Ambu A/S

Primary DI Number: 05707480133154
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305682023 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EOQ	BRONCHOSCOPE (FLEXIBLE OR RIGID)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Height: 175 Millimeter
Weight: 1500 Gram
Width: 241 Millimeter

Device Record Status

Public Device Record Key: c4d15dfc-6ccd-46c7-b7a2-9cedaf15ec47
Public Version Date: September 13, 2023
Public Version Number: 6
DI Record Publish Date: September 22, 2016