FDA Registration
Inactive
🇺🇸 United States
Millyard Advanced Medical Products LLC
·
Expires 2026
Products
5
Proprietary Names
6
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Millyard Advanced Medical Products LLC
- Status
- Inactive
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 350 Gay St
- City
- Manchester
- State
- NH
- ZIP
- 03103
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191313
Owner / Operator
- Firm Name
- Millyard Advanced Medical Products LLC
- Operator Number
- 10072764
- Address
- 540 Commercial Street, Suite 306
- City
- Manchester
- State
- NH
- Postal Code
- 03101
- Country
- US
- Correspondent
- Jay C Burkholder
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Infusion Pump, Drug Specific, Pharmacy-Filled | QJY | Class 2 | General Hospital | No | 2020-05-01 |
| Interoperable Automated Glycemic Controller | QJI | Class 2 | Clinical Chemistry | No | 2024-08-30 |
| Alternate Controller Enabled Insulin Infusion Pump | QFG | Class 2 | Clinical Chemistry | No | 2026-02-27 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2025-02-26 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2026-04-26 |
Proprietary Names
Remunity" Pump for Remodulin (treprostinil) Injection
Twiist Automated Insulin Delivery System
twiist Automated Insulin Delivery System
Remunity System
Remunity Pump for Remodulin (treprostinil) Injection
iiSure Infusion Set
Establishment Types
Manufacture Medical Device