AccessGUDID - DEVICE: ENDOTRACHEAL TUBE, WIRE REINFORCED, WITH CUFF (04544050082464)

GUDID

Device Identifier (DI) Information

Brand Name: ENDOTRACHEAL TUBE, WIRE REINFORCED, WITH CUFF
Version or Model: I.D. 7.5MM (FR.31), 400MM LONG TYPE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1200831
Company Name: FUJI SYSTEMS CORPORATION

Primary DI Number: 04544050082464
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 715919973 *Terms of Use

Device Description: Endotracheal Tubes are intended for oral intubation and are indicated for use in airway management and other suitable medical application.

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):	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?
46569	Reinforced endotracheal tube, single-use	An armoured 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 is wire reinforced to prevent kinking during patient movement and 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) have a built-in pilot balloon. It is typically made of plastic or rubber and is available in various diameters and lengths for adult and paediatric patients. 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 60c91a9c-131e-4d7e-bf3e-016f296ce88d
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2015