FDA Registration
Active
🇺🇸 United States
Anivia SG1000 Pump Console
Reg #: 3015431638
·
FEI: 3015431638
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- APMTD, INC.
- Registration Number
- 3015431638
- FEI Number
- 3015431638
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 226 Lowell Street, Unit B16
- City
- Wilmington
- State
- MA
- ZIP
- 01887
- Country
- US
Regulatory Submissions
- 510(k) Number
- K230698
Owner / Operator
- Firm Name
- APMTD, Inc.
- Operator Number
- 10060044
- Address
- 226 Lowell St, Unit B16
- City
- Wilmington
- State
- MA
- Postal Code
- 01887
- Country
- US
- Correspondent
- John Sasso
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Control, Pump Speed, Cardiopulmonary Bypass | DWA | Class 2 | Cardiovascular | No | 2023-04-25 |
Proprietary Names
Anivia SG1000 Pump Console
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198