AccessGUDID - DEVICE: TEXAS (04055207056752)

GUDID

Device Identifier (DI) Information

Brand Name: TEXAS
Version or Model: 825211030
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 825211030
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207056752
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: TRACHEAL SCOPE-TUBE ID 13MM OD 15.2mm, TL 338mm, for use with the optical element 82510.1400 and head systems 825101100 and 825101200, without distal viewing window, graduated, 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?
46218	Basic endotracheal tube, reusable	A hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated; it does not include an antimicrobial agent(s). The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is available in various diameters and lengths for adult and paediatric patients. This is a reusable 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: 13 Millimeter

Device Record Status

Public Device Record Key: 80130a9f-a158-409e-9a27-70de6b7ea9c7
Public Version Date: August 19, 2022
Public Version Number: 4
DI Record Publish Date: September 28, 2016