JOHN BUNN

Basic Information

• Brand Name: JOHN BUNN
• Primary DI: M368325581
• Version / Model: 3255-8
• Company Name: GF HEALTH PRODUCTS, INC.
• Labeler DUNS: 132016168
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 4
• Public Version Date: 2021-02-19
• Public Version Status: Update
• Public Device Record Key: ac5b2729-ddd0-485a-a1b9-a754769cb66e

Device Description

Jackson Trachea Plug

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	868.5800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62119	Tracheoesophageal speech valve occluder, non-valved	A device intended to be temporarily inserted into the tracheal end of a tracheoesophageal speech valve (typically indwelling type) to prevent leakage of fluids from the oesophagus into the trachea during swallowing; it is not intended to enable voice production. It is a synthetic polymer plug that includes a neck fastening strap and may include dedicated devices intended to assist insertion. It may be placed by a healthcare professional or by the patient and is intended to remain in position until medical attention can be obtained. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M368325581	HIBCC

Customer Contacts

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