FDA Registration
Active
🇺🇸 United States
EchoLong Needle/Catheter Set
Reg #: 3011270181
·
FEI: 3011270181
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Avanos Medical, Inc. (Formerly Halyard Health Inc.)
- Registration Number
- 3011270181
- FEI Number
- 3011270181
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 5405 Windward Parkway
- City
- Alpharetta
- State
- GA
- ZIP
- 30004
- Country
- US
Regulatory Submissions
- 510(k) Number
- K111355
Owner / Operator
- Firm Name
- Avanos Medical, Inc.
- Operator Number
- 2022573
- Address
- 5405 Windward Parkway, --
- City
- Alpharetta
- State
- GA
- Postal Code
- 30004
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Anesthesia Conduction Kit | CAZ | Class 2 | Anesthesiology | No | 2013-11-11 |
Proprietary Names
EchoLong Needle/Catheter Set
EchoBright Echogenic Regional Block Needle with Injection Set
EchoBright Echogenic PNB Needle
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility