DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756045872
• Version / Model: 81-060012
• Company Name: DEROYAL INDUSTRIES, INC.
• Labeler DUNS: 096372255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 80421640-800f-4593-b8f7-8808d8a2830c

Device Description

Esophageal Stethoscope w/o Temperature Sensor

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
BZT	STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS	Anesthesiology	868.1920	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44120	Electronic oesophageal stethoscope, single-use	An electronic listening device designed to be inserted into a patient's oesophagus to listen to heart and breathe sounds, typically while the patient is under anaesthesia. Some types may also have a temperature sensor to monitor the patient's temperature. The device will typically contain integral electrical conductors, thermistors/temperature sensors for proximal connection to a patient monitoring device, and include a proximal connector for a standard earpiece. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50749756045877	GS1	Case	50	In Commercial Distribution
Primary	00749756045872	GS1

Customer Contacts

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