FDA Registration
Inactive
🇺🇸 United States
butterflyBVM
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- 316 CONTRACT MANUFACTURING LLC
- Status
- Inactive
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 11850 Brookville Rd, Suite 21
- City
- Indianapolis
- State
- IN
- ZIP
- 46239
- Country
- US
Regulatory Submissions
- 510(k) Number
- K243861
Owner / Operator
- Firm Name
- 316 Contract Manufacturing LLC
- Operator Number
- 10093596
- Address
- 11850 Brookville Rd, Suite 21
- City
- Indianapolis
- State
- IN
- Postal Code
- 46239
- Country
- US
- Correspondent
- Jacob Flagle
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ventilator, Emergency, Manual (Resuscitator) | BTM | Class 2 | Anesthesiology | No | 2025-06-10 |
Proprietary Names
butterflyBVM
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)