FDA Registration
Active
🇺🇸 United States
Avanos2508 (EP1,EP2) - KimVent Microcuff
Reg #: 1643817
·
FEI: 1643817
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ISOMEDIX OPERATIONS INC
- Registration Number
- 1643817
- FEI Number
- 1643817
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1435 ISOMEDIX PLACE
- City
- EL PASO
- State
- TX
- ZIP
- 79936
- Country
- US
Regulatory Submissions
- 510(k) Number
- K080821
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 1527821
- Address
- 5960 Heisley Rd, --
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2022-04-22 |
Proprietary Names
Avanos2508 (EP1,EP2) - KimVent Microcuff
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)