FDA Registration
Active
🇺🇸 United States
NexSys PCS, Express Plus
Reg #: 3011773324
·
FEI: 3011773324
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Haemonetics Corporation
- Registration Number
- 3011773324
- FEI Number
- 3011773324
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1555 South Gramercy Rd, Ste 500
- City
- Salt Lake City
- State
- UT
- ZIP
- 84104
- Country
- US
Regulatory Submissions
- 510(k) Number
- BK220798
Owner / Operator
- Firm Name
- Haemonetics Corporation
- Operator Number
- 1219343
- Address
- 125 Summer St
- City
- Boston
- State
- MA
- Postal Code
- 02110
- Country
- US
- Correspondent
- Julie A Ryan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Separator, Automated, Blood Cell, Diagnostic | GKT | Class 2 | Hematology | No | 2023-06-21 |
Proprietary Names
NexSys PCS, Express Plus
Establishment Types
Manufacture Medical Device