JEM 365 Endotracheal Tube Changer

Basic Information

• Brand Name: JEM 365 Endotracheal Tube Changer
• Primary DI: M996JEM3650
• Version / Model: JEM 365
• Catalog Number: JEM 365
• Company Name: INSTRUMENTATION INDUSTRIES, INCORPORATED
• Labeler DUNS: 053146767
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2020-11-25
• Public Version Status: Update
• Public Device Record Key: d13f7efe-3656-4bea-888c-f4c37c3bf5ea

Device Description

JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. JEM 365 fits tubes with 6.5mm Inside Diameter.

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: No
• 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: ["High-level Disinfectant", "Ethylene Oxide", "Hydrogen Peroxide"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LNZ	Changer, Tube, Endotracheal	Anesthesiology	868.5730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42084	Endotracheal tube guide, single-use	A device used to provide guidance when it is necessary to exchange an endotracheal (ET) tube which has been intubated into a patient. The guide is inserted into the existing tube which is then retracted over the guide. The new ET tube is inserted over the guide to facilitate its correct passage, and the guide is removed once the new tube is satisfactorily in place. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M996JEM3652	HIBCC		10	In Commercial Distribution
Primary	M996JEM3650	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	5.54	Millimeter