FDA Registration
Active
🇺🇸 United States
ERBEFLO CleverCap® Hybrid Tubing/Cap Set for Fujifilm® Scopes
Reg #: 3020712480
·
FEI: 3020712480
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ERBE MEDICAL, LLC
- Registration Number
- 3020712480
- FEI Number
- 3020712480
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 405 W Geneva Dr
- City
- Tempe
- State
- AZ
- ZIP
- 85282
- Country
- US
Regulatory Submissions
- 510(k) Number
- K221177
Owner / Operator
- Firm Name
- Erbe Medical, LLC
- Operator Number
- 10083032
- Address
- 405 W Geneva Dr
- City
- Tempe
- State
- AZ
- Postal Code
- 85282
- Country
- US
- Correspondent
- Kyle Donnelly
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Endoscopic Irrigation/Suction System | OCX | Class 2 | Gastroenterology, Urology | No | 2023-09-19 |
Proprietary Names
ERBEFLO CleverCap® Hybrid Tubing/Cap Set for Fujifilm® Scopes
ERBEFLO AeroRinse® Air and Water Tubing/Cap Set for Olympus® Scopes
ERBEFLO CleverCap® Hybrid Tubing/Cap Set for Olympus® Scopes
ERBEFLO CleverCap® Hybrid OFP & EndoStat Tubing/Cap Set for Olympus® Scope
ERBEFLO AeroRinse® Air and Water Tubing/Cap Set for Fujinon® Scopes
ERBEFLO CleverCap® Hybrid Tubing/Cap Set for Pentax® Scopes
ERBEFLO AeroRinse® Air and Water Tubing/Cap Set for Pentax® Scopes
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device