E-Scope 718-7700

GUDID B37571877000

Clinical E-Scope

CARDIONICS INC

Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope

• Primary Device ID: B37571877000
• NIH Device Record Key: e4e00cbc-7d3f-421d-8d21-51a80af07171
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E-Scope
• Version Model Number: 7187700
• Catalog Number: 718-7700
• Company DUNS: 018076950
• Company Name: CARDIONICS 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B37571877000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961301

FDA Product Code

• DQD: Stethoscope, Electronic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-19

Devices Manufactured by CARDIONICS INC

• B37571877000 - E-Scope: 2018-07-06Clinical E-Scope
• B37571877000 - E-Scope: 2018-07-06 Clinical E-Scope
• B37871877100 - E-Scope Hearing Impaired: 2018-07-06 E-Scope Hearing Impaired