FDA Registration
Active
🇺🇸 United States
SHIKANI MEDICAL LLC
Reg #: 3008278458
·
FEI: 3008278458
·
Expires 2026
Products
3
Proprietary Names
4
Establishment Types
2
Classifications
3
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Registration Details
- Registration Name
- SHIKANI MEDICAL LLC
- Registration Number
- 3008278458
- FEI Number
- 3008278458
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1629 York Road
- City
- Lutherville
- State
- MD
- ZIP
- 21093
- Country
- US
Regulatory Submissions
- 510(k) Number
- K100995
Owner / Operator
- Firm Name
- Shikani Medical LLC (d/b/a The Airway Company)
- Operator Number
- 10031493
- Address
- 1629 York Road
- City
- Lutherville
- State
- MD
- Postal Code
- 21093
- Country
- US
- Correspondent
- Patrick A Shikani
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2011-07-20 |
| Tube Tracheostomy And Tube Cuff | JOH | Class 2 | Anesthesiology | No | 2010-06-30 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2019-05-08 |
Proprietary Names
HME for use with Shikani Speaking valves
Shikani speaking valves
SSV2 speaking valve
oxygen tubing
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device