Stethoscope duplex® 2.0 "black edition" 4201-01

GUDID 04045396195424

Stethoscopes are sound-conducting instruments to be used for auscultation of body and organ sounds, especially of heart and lung; meaning they are used in order to diagnose illness of internal organs. In medical science, doctors or other trained medical professionals use a stethoscope in order to assess sounds and noises linked with the function of heart, lung and bowel. During blood pressure measurement, a stethoscope is used to capture Korotkow blood flow murmur (Korotkow sounds) leading to determination of systolic and diastolic blood pressure.

Rudolf Riester GmbH

Mechanical stethoscope

• Primary Device ID: 04045396195424
• NIH Device Record Key: 75ed843a-3273-497b-a7a5-cd1ce56795cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stethoscope duplex® 2.0 "black edition"
• Version Model Number: 4201-01
• Catalog Number: 4201-01
• Company DUNS: 537208717
• Company Name: Rudolf Riester GmbH
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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
GS1	04045396195424 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944337

FDA Product Code

• LDE: Stethoscope, Manual

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: 2021-02-05
• Device Publish Date: 2021-01-28

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