FDA Registration
Active
🇺🇸 United States
2F3133
Reg #: 3006793151
·
FEI: 3006793151
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GURIN PRODUCTS LLC
- Registration Number
- 3006793151
- FEI Number
- 3006793151
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2522 Chambers Rd Ste 100
- City
- Tustin
- State
- CA
- ZIP
- 92780
- Country
- US
Regulatory Submissions
- 510(k) Number
- K122482
Owner / Operator
- Firm Name
- Gurin Products, LLC
- Operator Number
- 10031258
- Address
- 2522 Chambers Rd, Suite 100
- City
- Tustin
- State
- CA
- Postal Code
- 92780
- Country
- US
- Correspondent
- Sanjay Gupta
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2018-08-14 |
Proprietary Names
2F3133
AccuraPulse AP-WBPM810
TMB-1580
Establishment Types
Repack or Relabel Medical Device