AccessGUDID - DEVICE: aScope™ 3 Large 5.8/2.8Flexible Videoscope

GUDID

Device Identifier (DI) Information

Brand Name: aScope™ 3 Large 5.8/2.8Flexible Videoscope - Single Use
Version or Model: 414001000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 414001000
Company Name: Ambu A/S

Primary DI Number: 05707480133109
Issuing Agency: GS1
Commercial Distribution End Date: May 11, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 305682023 *Terms of Use

Device Description: Ambu aScope 3 Large 5.8/2.8 Single-use flexible scope with insertion cord diameter of 5.8 mm and channel width up to 2.8 mm. Min. purchase is 5 pcs. = 1 box

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?
60963	Flexible video bronchoscope, single-use	An 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 typically intended for flexible optical intubation, airway inspection, and may be used to assist in other diagnostic or therapeutic procedures [e.g., bronchoalveolar lavage (BAL)]. This is a single-use device.	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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 2.8 Millimeter
Outer Diameter: 5.8 Millimeter
Device Size Text, specify: Size 3
Length: 600 Millimeter

Device Record Status

Public Device Record Key: 00bfb55a-b4b4-4264-b8f2-092c08d546f0
Public Version Date: May 12, 2023
Public Version Number: 6
DI Record Publish Date: September 21, 2016