Stylet – Tracheal Tube/ Bougie Catheter

Basic Information

• Brand Name: Stylet – Tracheal Tube/ Bougie Catheter
• Primary DI: 00860004198864
• Version / Model: CM002
• Catalog Number: CM002
• Company Name: GMMI SDN. BHD.
• Labeler DUNS: 865757421
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-23
• Public Version: 1
• Public Version Date: 2025-06-02
• Public Version Status: New
• Public Device Record Key: 89f7ecbd-e8bd-4c78-9f56-6369ce222bae

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BSR	Stylet, Tracheal Tube	Anesthesiology	868.5790	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41829	Endotracheal tube introducer, single-use	A device designed to help with the insertion of an endotracheal (ET) tube into the airways of a patient during intubation. It is a long, thin, rod-like device, typically angled at the distal end, designed to improve directional control of the endotracheal tube during routine or difficult oral intubations. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10860004198861	GS1	Box	10	In Commercial Distribution
Primary	00860004198864	GS1
Package	20860004198868	GS1	Carton	30	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]