AccessGUDID - DEVICE: NA (06974599110478)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: TRI-2
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Changsha Magill Medical Technology Co., Ltd.

Primary DI Number: 06974599110478
Issuing Agency: GS1
Commercial Distribution End Date: January 22, 2025
Device Count: 50
Labeler D-U-N-S® Number*: 703075567 *Terms of Use

Device Description: A 3-way connector where one of the open is capped. Allow passage of suction cathers or bronchoscopes.

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?
63465	Closed-suction breathing circuit connector/switch	A sterile length of tube with valves intended to create a closed three-way connection between an endotracheal tube, a ventilator/anaesthesia unit, and a suction pump to eliminate the need to disconnect the breathing circuit for secretion suctioning. The valves are intended to be manually-operated to isolate parts of the circuit and control suction, and the device may include a port(s) for the administration of fluids such as saline. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)

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: 818563fc-1e37-4d8c-aebc-4050314cd2bb
Public Version Date: February 20, 2025
Public Version Number: 2
DI Record Publish Date: January 13, 2023