FDA Registration
Active
🇮🇱 Israel
SunTech Cuff, All purpose general (Adult)
Reg #: 3005004021
·
FEI: 3005004021
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Baxter Healthcare - Tel Aviv
- Registration Number
- 3005004021
- FEI Number
- 3005004021
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2A Hashlosha St. F-32
- City
- Tel Aviv
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K051904
Owner / Operator
- Firm Name
- BAXTER HEALTHCARE CORPORATION
- Operator Number
- 1417572
- Address
- One Baxter Parkway
- City
- Deerfield
- State
- IL
- Postal Code
- 60015
- Country
- US
- Correspondent
- Maha Nolasco
US Agent
- Business Name
- BAXTER HEALTHCARE CORPORATION
- Contact Name
- Maha Nolasco
- Address
- 25212 W. IL Route 120, RLT-04
- City
- Round Lake
- State
- IL
- ZIP
- 60073
- Country
- US
- [email protected]
- Phone
- 224 2706181
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2023-12-06 |
Proprietary Names
SunTech Cuff, All purpose general (Adult)
SunTech Cuff, All purpose general (Adult Large)
Establishment Types
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device