FDA UDI
In Commercial Distribution
🇺🇸 United States
CORE 500 Digital Stethoscope - Bundle-CHP
DI: 00850010298801
·
Model: E8
·
Eko Devices, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CORE 500 Digital Stethoscope - Bundle-CHP
- Primary DI
- 00850010298801
- Version / Model
- E8
- Catalog Number
- COR503-CHP/CHP
- Company Name
- Eko Devices, Inc.
- Labeler DUNS
- 079670921
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-12
- Public Version
- 1
- Public Version Date
- 2025-08-20
- Public Version Status
- New
- Public Device Record Key
- b98dd2af-852b-4598-ac67-bb0460f96b14
Device Description
CORE 500 Digital Stethoscope - Bundle-CHP
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| DQD | Stethoscope, Electronic | Cardiovascular | 870.1875 | 2 |
| DPS | Electrocardiograph | Cardiovascular | 870.2340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13754 | Electronic acoustic stethoscope | An external, hand-held, electronic listening device designed to be used by a healthcare professional for real-time detection and amplification of body sounds (e.g., heart, blood vessels, lungs) that may be difficult to perceive when using a mechanical stethoscope; it is not designed for electrocardiography (ECG). It is typically designed to be connected to a computing device, which may operate interpretive software sometimes provided with the stethoscope, for recording and/or displaying the results in the form of a graph [phonocardiogram (PCG)]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850010298801 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233609 | 000 |