LIFESOUND

Basic Information

• Brand Name: LIFESOUND
• Primary DI: 00817499020026
• Version / Model: 10-1550-001
• Company Name: NOVAMED-USA INC.
• Labeler DUNS: 831531426
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-21
• Public Version: 4
• Public Version Date: 2021-03-15
• Public Version Status: Update
• Public Device Record Key: 55c482cc-c1cf-476c-8c4d-299615e42425

Device Description

18FR ESOPHAGEAL STETHOSCOPE WITH 400 SERIES THERMISTOR

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: 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	20817499020020	GS1	CASE	4	In Commercial Distribution
Package	10817499020023	GS1	BOX	40	In Commercial Distribution
Primary	00817499020026	GS1

Customer Contacts

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