FDA UDI
In Commercial Distribution
🇺🇸 United States
Keikku Digital Stethoscope
DI: 06429811134003
·
Model: KEIKKUGEN1
·
Lapsi Health Holding B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Keikku Digital Stethoscope
- Primary DI
- 06429811134003
- Version / Model
- KEIKKUGEN1
- Company Name
- Lapsi Health Holding B.V.
- Labeler DUNS
- 494111993
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-16
- Public Version
- 1
- Public Version Date
- 2025-10-24
- Public Version Status
- New
- Public Device Record Key
- a864bc50-b56d-451f-96a7-15c8367c19bf
Device Description
Keikku Digital Stethoscope
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| DQD | Stethoscope, Electronic | Cardiovascular | 870.1875 | 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 | 06429811134003 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233313 | 000 |