FDA Registration
Active
🇺🇸 United States
Numa II Full Face Mask (F4) - (Device Modification) ((Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)
Reg #: 3009096682
·
FEI: 3009096682
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- 3B Medical Inc
- Registration Number
- 3009096682
- FEI Number
- 3009096682
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 5475 Rings Road, Suite 550
- City
- Dublin
- State
- OH
- ZIP
- 43017
- Country
- US
Regulatory Submissions
- 510(k) Number
- K163464
Owner / Operator
- Firm Name
- React Health
- Operator Number
- 10040143
- Address
- 5475 Rings Road, Suite 550
- City
- Dublin
- State
- OH
- Postal Code
- 43017
- Country
- US
- Correspondent
- Margaret Mangano
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2023-01-17 |
Proprietary Names
Numa II Full Face Mask (F4) - (Device Modification) ((Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)
F2 Single-Patient Vented Full Face Mask (BMC-FM2) - (Device Modification) ((BMC-NM Nasal Mask, BMC-NM2 Nasal Mask
Viva Nasal Mask (Model: NM4) (Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2))
Numa Full Face Mask (BMC-FM2) ((Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2))
Establishment Types
Complaint File Establishment per 21 CFR 820.198