AccessGUDID - DEVICE: Insighters (06970831723635)

GUDID

Device Identifier (DI) Information

Brand Name: Insighters
Version or Model: Ordinary Right type 39Fr
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shenzhen Insighters Medical Technology Co., Ltd.

Primary DI Number: 06970831723635
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 551096917 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
32158	Tracheobronchial suction/insufflation catheter, dual-lumen	A sterile flexible tube designed for periodic tracheal and pharyngeal mucus aspiration and inflation of the lungs with a flow of gas from its distal tip. It consists of a dual-lumen tube which allows simultaneous suction and insufflation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CBI	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K232529	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: eb3beaf7-fd04-4829-85aa-6188bff78241
Public Version Date: April 20, 2026
Public Version Number: 1
DI Record Publish Date: April 10, 2026