JOHN BUNN

Basic Information

• Brand Name: JOHN BUNN
• Primary DI: M3681398171
• Version / Model: 1398-1#7
• 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: 3
• Public Version Date: 2019-07-25
• Public Version Status: Update
• Public Device Record Key: 7367db3c-d8fc-4420-a40e-0f1424db7de4

Device Description

Jackson Trachea Tube Standard Length

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
42419	Oesophageal-obturating/tracheal airway, reusable	A two-lumen, semiflexible, tube inserted blindly through the mouth into the oesophagus or trachea to maintain airway patency while obturating the oesophagus, typically during emergencies to facilitate breathing/resuscitation. The lumen has a blocked distal end and perforations at the pharyngeal level. The tracheal lumen is open at both ends. A large oropharyngeal balloon seals mouth and nose; a distal cuff seals either the oesophagus or the trachea. Ventilation starts via the oesophageal tube, if the tube is in the oesophagus air enters the pharynx via the perforations; when the tube is in the trachea the ventilation is performed directly through the tracheal tube. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M3681398171	HIBCC

Customer Contacts

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