AccessGUDID - DEVICE: NA (06974599110485)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: EJT-1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Changsha Magill Medical Technology Co., Ltd.

Primary DI Number: 06974599110485
Issuing Agency: GS1
Commercial Distribution End Date: January 12, 2025
Device Count: 100
Labeler D-U-N-S® Number*: 703075567 *Terms of Use

Device Description: This device helps to hold the endotracheal tube in position when exchanging a in situ laryngeal mask after endotracheal tube is in place.

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?
60376	Endotracheal tube stabilization rod	A non-sterile device intended to be used to facilitate exchange of an in situ laryngeal airway for an endotracheal tube (ETT) by stabilizing the position of the inserted ETT as the laryngeal airway is withdrawn. It typically consists of a semi-flexible rod which functions as an extension of the ETT during the exchange. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BSR	Stylet, Tracheal Tube

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: 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: bb99417e-9c86-4b75-89b9-e68e55171710
Public Version Date: February 20, 2025
Public Version Number: 2
DI Record Publish Date: January 13, 2023