FDA Registration
Active
🇺🇸 United States
NOxBOXi Nitric Oxide Delivery System
Reg #: 3012160128
·
FEI: 3012160128
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
3
Classifications
5
Registration Details
- Registration Name
- Linde Gas & Equipment Inc.
- Registration Number
- 3012160128
- FEI Number
- 3012160128
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 208 N Main St
- City
- Livingston
- State
- TN
- ZIP
- 38570
- Country
- US
Regulatory Submissions
- 510(k) Number
- K171696
Owner / Operator
- Firm Name
- Linde Gas & Equipment Inc.
- Operator Number
- 9915062
- Address
- 7000 High Grove Blvd.
- City
- Burr Ridge
- State
- IL
- Postal Code
- 60527
- Country
- US
- Correspondent
- Michael - Larsen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Nitric Oxide | MRP | Class 2 | Anesthesiology | No | 2019-08-20 |
| Apparatus, Nitric Oxide, Backup Delivery | MRO | Class 2 | Anesthesiology | No | 2019-08-20 |
| Analyzer, Nitrogen Dioxide | MRQ | Class 2 | Anesthesiology | No | 2019-08-20 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2019-08-20 |
| Apparatus, Nitric Oxide Delivery | MRN | Class 2 | Anesthesiology | No | 2019-08-20 |
Proprietary Names
NOxBOXi Nitric Oxide Delivery System
Establishment Types
Remanufacture Medical Device
Manufacture Medical Device
Repack or Relabel Medical Device