Identity
- Trade Name
- Teaching stethoscope duplex®, slate-grey, FDA UDI
- Generic Name
- Mechanical external stethoscope FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 4002-02 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 4002-02 FDA UDI
- Primary DI / UDI-DI
- 04045396118683 FDA UDI
- 510(k) Number
- K944337 FDA UDI
- FDA Product Code
- LDE FDA UDI
- GMDN Term
- Mechanical external stethoscope FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.1875 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Mechanical external stethoscope
Teaching stethoscope duplex®, slate-grey, by Rudolf Riester GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mechanical external stethoscope.
- Sklar® — Sklar Corporation · Class I
- Adscope® — American Diagnostic Corporation · Class I
- Stethoscope — Rashman Corp. · Class I
- Greater Goods — Greater Goods, LLC · Class I
- Stethoscope — Rashman Corp. · Class I
- 3M™ Littmann® Classic III™ — 3M COMPANY · Class I
- Proscope™ — American Diagnostic Corporation · Class I
- Adscope® — American Diagnostic Corporation · Class I
Cleared under the same submission
K944337 also covers:
- Stethoscope anestophon, blue, aluminium, — Rudolf Riester GmbH & Co. KG
- Stethoscope anestophon, green, aluminium, — Rudolf Riester GmbH & Co. KG
- Stethoscope anestophon, slate-grey, aluminium, — Rudolf Riester GmbH & Co. KG
- Stethoscope cardiophon 2.0, black — Rudolf Riester GmbH & Co. KG
- Stethoscope cardiophon 2.0, blue, — Rudolf Riester GmbH & Co. KG
- Stethoscope cardiophon 2.0, burgundy — Rudolf Riester GmbH & Co. KG
- Stethoscope duplex® 2.0 "black edition" — Rudolf Riester GmbH & Co. KG
- Stethoscope duplex® 2.0 baby, black, — Rudolf Riester GmbH & Co. KG
- Stethoscope duplex® 2.0 baby, green, — Rudolf Riester GmbH & Co. KG
- Stethoscope duplex® 2.0 baby, red, — Rudolf Riester GmbH & Co. KG
- Stethoscope duplex® 2.0 baby, white, — Rudolf Riester GmbH & Co. KG
- Stethoscope duplex® 2.0 black — Rudolf Riester GmbH & Co. KG
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Rudolf Riester GmbH & Co. KG
Sources (1)
- FDA UDI 729c69bd-4ec5-4e94-af93-d09e512dec43 35 fields · synced May 30, 2026