FDA Registration
Active
🇺🇸 United States
Nellcor All Types
Reg #: 3034520
·
FEI: 3003350313
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- RENU MEDICAL, INC.
- Registration Number
- 3034520
- FEI Number
- 3003350313
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5900 36th Ave W Ste 100
- City
- EVERETT
- State
- WA
- ZIP
- 98203
- Country
- US
Regulatory Submissions
- 510(k) Number
- K072194
Owner / Operator
- Firm Name
- RENU MEDICAL, INC.
- Operator Number
- 9046359
- Address
- 5900 36th Ave West, Bldg B, Suite 100
- City
- Everett
- State
- WA
- Postal Code
- 98203
- Country
- US
- Correspondent
- John - Petrush
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter, Reprocessed | NLF | Class 2 | Cardiovascular | No | 2007-12-04 |
Proprietary Names
Nellcor All Types
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Reprocess Single-Use Device
Repack or Relabel Medical Device