AccessGUDID - DEVICE: aScope™ 2Flexible Intubation Scope (05707480119493)

GUDID

Device Identifier (DI) Information

Brand Name: aScope™ 2Flexible Intubation Scope
Version or Model: 400002005
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 400002005
Company Name: Ambu A/S

Primary DI Number: 05707480119493
Issuing Agency: GS1
Commercial Distribution End Date: May 21, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 305682023 *Terms of Use

Device Description: Ambu aScope2

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":	Yes
For Single-Use:	Yes
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?
56653	Flexible video intubation laryngoscope, single-use	A sterile endoscope with a flexible inserted portion intended for the visual examination of the trachea, and to assist the entry and positioning of an airway tube, typically an endotracheal (ET) tube, to secure an open airway in the case of difficult and non-difficult intubation procedures. The inserted portion is thin and long to facilitate endoscope entry and the intubation procedure. Anatomical images are transmitted to the user by a video system with an electronic camera at the distal end of the endoscope and the images showing on a monitor. It is typically used during difficult and non-difficult intubation procedures when maintaining an airway open. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTR	Tube, tracheal (w/wo connector)

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 80 and 109 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Size 2

Device Record Status

Public Device Record Key: 6a5c55ad-beaa-46f9-8882-24e8e1c94803
Public Version Date: May 22, 2019
Public Version Number: 3
DI Record Publish Date: January 07, 2016