Cardiart Electronic Stethoscope

GUDID 04719874400019

The Electronic Stethoscope DS101 is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior ch

IMEDIPLUS INC.

Electronic stethoscope

• Primary Device ID: 04719874400019
• NIH Device Record Key: f5c8a059-6e68-413e-a993-248376f1fa6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardiart Electronic Stethoscope
• Version Model Number: DS101
• Company DUNS: 658869745
• Company Name: IMEDIPLUS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719874400019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182196

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: 1
• Public Version Date: 2019-02-08
• Device Publish Date: 2019-01-08

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