FDA UDI
In Commercial Distribution
🇺🇸 United States
Sprague Rappaport Stethoscope Amplifies Heart & Lung Sounds,Blue
DI: 00616784713625
·
Model: 7136
·
Dynarex Corporation
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Sprague Rappaport Stethoscope Amplifies Heart & Lung Sounds,Blue
- Primary DI
- 00616784713625
- Version / Model
- 7136
- Company Name
- Dynarex Corporation
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-22
- Public Version
- 4
- Public Version Date
- 2024-11-25
- Public Version Status
- Update
- Public Device Record Key
- c168d82b-a15c-4d4f-bae3-5cce52dc2903
Device Description
Complete Kit Includes: 3 Sets of eartips, Large & Small diaphragm, Diaphragm removal tool, Adult, Pediatric & Infant bells, Dual tubing that transmits faint sounds.
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- Yes
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 external stethoscope | A non-powered, external listening device designed to be placed on the patient’s skin to listen sounds from the arms, 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 user’s ears. This is a reusable device. | No | Active |
| 32659 | Foetal stethoscope | A mechanical listening device that is used for listening to foetal heart sounds. It is typically designed as a hollow tube (trumpet-shaped) to transmit the foetal heart sound through the inner channel by air conduction and is pressed against the outside of the mother's abdomen and the user will place their head and ear to the listening end of the device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00616784713632 | GS1 | Case | 20 | In Commercial Distribution | |
| Primary | 00616784713625 | GS1 |