LIFESOUND

GUDID 20817499020037

24FR ESOPHAGEAL STETHOSCOPE WITH 400 SERIES THERMISTOR

NOVAMED-USA INC.

Electronic oesophageal stethoscope, single-use Electronic oesophageal stethoscope, single-use Electronic oesophageal stethoscope, single-use Electronic oesophageal stethoscope, single-use Electronic oesophageal stethoscope, single-use Electronic oesophageal stethoscope, single-use Electronic oesophageal stethoscope, single-use Electronic oesophageal stethoscope, single-use Electronic oesophageal stethoscope, single-use Electronic oesophageal stethoscope, single-use Electronic oesophageal stethoscope, single-use Electronic oesophageal stethoscope, single-use Electronic oesophageal stethoscope, single-use Electronic oesophageal stethoscope, single-use

• Primary Device ID: 20817499020037
• NIH Device Record Key: 00051021-a667-4020-a1f2-bf50868c2c47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIFESOUND
• Version Model Number: 10-1560-001
• Company DUNS: 831531426
• Company Name: NOVAMED-USA INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 914-789-2100
• Email: info@novamed-usa.com
• Phone: 914-789-2100
• Email: info@novamed-usa.com
• Phone: 914-789-2100
• Email: info@novamed-usa.com
• Phone: 914-789-2100
• Email: info@novamed-usa.com
• Phone: 914-789-2100
• Email: info@novamed-usa.com
• Phone: 914-789-2100
• Email: info@novamed-usa.com
• Phone: 914-789-2100
• Email: info@novamed-usa.com
• Phone: 914-789-2100
• Email: info@novamed-usa.com
• Phone: 914-789-2100
• Email: info@novamed-usa.com
• Phone: 914-789-2100
• Email: info@novamed-usa.com
• Phone: 914-789-2100
• Email: info@novamed-usa.com
• Phone: 914-789-2100
• Email: info@novamed-usa.com
• Phone: 914-789-2100
• Email: info@novamed-usa.com
• Phone: 914-789-2100
• Email: info@novamed-usa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817499020033 [Primary]
GS1	10817499020030 [Package]; Contains: 00817499020033; Package: BOX [40 Units]; In Commercial Distribution
GS1	20817499020037 [Package]; Contains: 10817499020030; Package: CASE [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062020

FDA Product Code

• BZT: Stethoscope, Esophageal, With Electrical Conductors

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-02

On-Brand Devices [LIFESOUND]

• 20817499020211: 18FR ESOPHAGEAL STETHOSCOPE WITH 700 SERIES THERMISTOR
• 20817499020037: 24FR ESOPHAGEAL STETHOSCOPE WITH 400 SERIES THERMISTOR
• 20817499020020: 18FR ESOPHAGEAL STETHOSCOPE WITH 400 SERIES THERMISTOR
• 20817499020013: 12FR ESOPHAGEAL STETHOSCOPE WITH 400 SERIES THERMISTOR
• 20817499020006: 9FR ESOPHAGEAL STETHOSCOPE WITH 400 SERIES THERMISTOR
• 10817499020306: 24FR esophageal stethoscope/400 series sterile - each
• 10817499020290: 18FR esophageal stethoscope/400 series sterile - each
• 10817499020283: 12FR esophageal stethoscope/400 series sterile - each
• 10817499020108: 9FR esophageal stethoscope/400 series sterile - each