FDA UDI
In Commercial Distribution
🇺🇸 United States
Stethoscope duplex® 2.0 baby, green,
DI: 04045396195509
·
Model: 4220-05
·
Rudolf Riester GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Stethoscope duplex® 2.0 baby, green,
- Primary DI
- 04045396195509
- Version / Model
- 4220-05
- Catalog Number
- 4220-05
- Company Name
- Rudolf Riester GmbH
- Labeler DUNS
- 537208717
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-28
- Public Version
- 1
- Public Version Date
- 2021-02-05
- Public Version Status
- New
- Public Device Record Key
- c57c4087-e4e6-465d-a44a-8fe92abfdb6f
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LDE | Stethoscope, Manual | Cardiovascular | 870.1875 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13755 | Mechanical stethoscope | A mechanical listening device designed for listening to sounds from the heart, lungs, and/or gastrointestinal tract. It typically comprises a membrane at the listening head connected by a split "Y" tube to the headgear with ear olives that are placed into the users ears. Mechanical stethoscopes are typically found in two variants 1) a general-purpose stethoscope used for clinical/ward activities; or 2) a reinforced stethoscope used by cardiologists. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04045396195509 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K944337 | 000 |