Shure

Basic Information

• Brand Name: Shure
• Primary DI: 00817613020093
• Version / Model: DRS340
• Company Name: MED X CHANGE, INC.
• Labeler DUNS: 051244569
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 89bef476-2e48-40fa-89aa-189d2090fd6c

Device Description

Microphone headset transmitter/receiver for voice recognition

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
36768	Freestanding microphone	A freestanding electroacoustic transducer designed to capture sound waves, usually vocal, and convert them into electrical signals that are amplified typically for various medical communication/recording or patient-assistive applications. It is not permanently attached to or integrated into another device and may operate via wireless technology. It is typically hand held, attached to clothing, or placed in a holder.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817613020093	GS1