FDA UDI
In Commercial Distribution
🇺🇸 United States
Cardiart TS6000 Premium Cardiology Stethoscope
DI: 04719874400088
·
Model: TS6000 Premium
·
IMEDIPLUS INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cardiart TS6000 Premium Cardiology Stethoscope
- Primary DI
- 04719874400088
- Version / Model
- TS6000 Premium
- Company Name
- IMEDIPLUS INC.
- Labeler DUNS
- 658869745
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-03
- Public Version
- 1
- Public Version Date
- 2019-09-11
- Public Version Status
- New
- Public Device Record Key
- 9e5888c1-c759-431a-81ca-e95c00616f08
Device Description
Cardiart TS6000 Premium Cardiology Stethoscope aids to the auscultation needs and is designed to suit the individual requirement for each physician. The chestpiece is easy to grip with finger contoured holder and the ear tips with the soft texture are comfortable to wear, moreover, it could provide a good sealant for reducing environmental noise and offer a good sound quality for users.
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
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 04719874400088 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 31.60 | Millimeter | |
| Outer Diameter | 45 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 50 Degrees Celsius