AccessGUDID - DEVICE: Broncoflex Vortex (03664977010034)

GUDID

Device Identifier (DI) Information

Brand Name: Broncoflex Vortex
Version or Model: 10030001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10030001
Company Name: AXESS VISION TECHNOLOGY

Primary DI Number: 03664977010034
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 285985615 *Terms of Use

Device Description: Broncoflex Vortex is a single-use video-bronchoscope which is part of a system made up of the endoscope (Broncoflex) and its reusable display monitor (Screeni). 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":	No
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 [?]
K202180	000

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 Atmospheric Pressure: between 80 and 109 KiloPascal
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 80 and 109 KiloPascal
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 2.8 Millimeter
Outer Diameter: 5.6 Millimeter
Length: 605 Millimeter

Device Record Status

Public Device Record Key: a3016bf5-c9b1-4a1f-8879-ea478b8714c8
Public Version Date: February 03, 2023
Public Version Number: 2
DI Record Publish Date: December 10, 2020