FDA Registration
Active
🇺🇸 United States
Hypodermic Needle, Pink, 18GA x 1.5"
Reg #: 3015997711
·
FEI: 3015997711
·
Expires 2025
Products
3
Proprietary Names
2
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- KATMAI INTEGRATED SOLUTIONS
- Registration Number
- 3015997711
- FEI Number
- 3015997711
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 34 Kelley Way
- City
- Brilliant
- State
- OH
- ZIP
- 43913
- Country
- US
Regulatory Submissions
- 510(k) Number
- K021475
Owner / Operator
- Firm Name
- Katmai Health Services, LLC
- Operator Number
- 10050389
- Address
- 701 E. Tudor Rd., Suite 215
- City
- Anchorage
- State
- AK
- Postal Code
- 99503
- Country
- US
- Correspondent
- Lisa Talkington
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2016-04-08 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2016-04-08 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2016-04-08 |
Proprietary Names
Hypodermic Needle, Pink, 18GA x 1.5"
Hypodermic Needle, Black, 22GA x 1"
Establishment Types
Repack or Relabel Medical Device