FDA UDI
Not in Commercial Distribution
🇺🇸 United States
VIVA Pump
DI: 08809306769015
·
Model: VP01
·
STARMED CO.,LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- VIVA Pump
- Primary DI
- 08809306769015
- Version / Model
- VP01
- Catalog Number
- VP01
- Company Name
- STARMED CO.,LTD
- Labeler DUNS
- 694699723
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-19
- Public Version
- 5
- Public Version Date
- 2019-07-05
- Public Version Status
- Update
- Public Device Record Key
- 10e7dd4d-e5f1-414f-8254-5061015e0e21
- Distribution End Date
- 2019-07-04
Device Description
The peristaltic pump, VIVA Pump, is used to provide the cooling of the electrodes, star RF Electrode. The chilled water is pumped through the inflow tubing, the electrode and out through the outflow tubing. This is enclosed system within the electrode and the water is not to be in contact with the patient.
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
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37147 | Cooling utility supply system | An assembly of devices designed to provide utilities/amenities (e.g., water, compressed air) to cool other medical devices, data equipment, or laboratory devices/equipment to facilitate their operation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809306769015 | GS1 |
Customer Contacts
- Phone
- +82318163546
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163450 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 4 | Kilogram | |
| Depth | 135 | Millimeter | |
| Height | 160 | Millimeter | |
| Width | 193 | Millimeter |