Stylet – Tracheal Tube/ Bougie Catheter

Basic Information

• Brand Name: Stylet – Tracheal Tube/ Bougie Catheter
• Primary DI: 00860004198802
• Version / Model: CM001
• Catalog Number: CM001
• Company Name: GMMI SDN. BHD.
• Labeler DUNS: 865757421
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-08
• Public Version: 3
• Public Version Date: 2020-12-21
• Public Version Status: Update
• Public Device Record Key: e2cde0e8-0a52-4732-9070-9babe9d12123

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• 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
63633	Tracheostomy tube guidewire	A sterile wire intended to assist manual introduction of a tracheostomy tube guide-catheter used to facilitate the insertion or reinsertion of a tracheostomy tube into the trachea through the skin after a percutaneous tracheotomy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10860004198809	GS1	Box	10	In Commercial Distribution
Primary	00860004198802	GS1
Package	20860004198806	GS1	Carton	30	In Commercial Distribution

Customer Contacts

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