AccessGUDID - DEVICE: NA (04055207033500)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 825103028
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 82510.3028
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207033500
Issuing Agency: GS1
Commercial Distribution End Date: March 02, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: BRONCHOSCOPE-TUBE ID 3.2MM by Nicolai-Mantel, OD 3.8mm, TL 280mm, without proximal light connection, without distal viewing window, reusable

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):	No
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?
41126	Bronchoscopy tube	A hollow cylinder composed of plastic, rubber, or other material that is inserted orally into the trachea to maintain airway patency and/or to deliver anaesthetic inhalation agents or other medical gases, and secure ventilation during diagnostic or therapeutic bronchoscopy using a flexible bronchoscope. It has a cuff at the distal end, similar to that of a cuffed endotracheal (ET) tube and may be packaged with a connector that attaches to a breathing circuit. It has a large enough bore to accommodate a flexible bronchoscope; this can enhance the safety of the procedure. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KTI	BRONCHOSCOPE ACCESSORY

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 3.2 Millimeter

Device Record Status

Public Device Record Key: daf4ecce-bbb2-4236-af8c-ccfe0f62078a
Public Version Date: August 19, 2022
Public Version Number: 3
DI Record Publish Date: September 26, 2016