FDA Registration
Active
🇺🇸 United States
RENU MEDICAL, INC.
Reg #: 3034520
·
FEI: 3003350313
·
Expires 2026
Products
8
Proprietary Names
17
Establishment Types
3
Classifications
8
Registration Details
- Registration Name
- RENU MEDICAL, INC.
- Registration Number
- 3034520
- FEI Number
- 3003350313
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5900 36th Ave W Ste 100
- City
- EVERETT
- State
- WA
- ZIP
- 98203
- Country
- US
Regulatory Submissions
- 510(k) Number
- K031559
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 |
|---|---|---|---|---|---|
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2007-12-04 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2014-12-03 |
| Monitor, Bed Patient | KMI | Class 1 | General Hospital | No | 2022-07-21 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2016-04-18 |
| Oximeter, Reprocessed | NLF | Class 2 | Cardiovascular | No | 2007-12-04 |
| Infusor, Pressure, For I.V. Bags | KZD | Class 1 | General Hospital | No | 2004-11-17 |
| Tourniquet, Pneumatic | KCY | Class 1 | General, Plastic Surgery | No | 2008-05-30 |
| Lift, Patient, Non-Ac-Powered | FSA | Class 1 | General Hospital | No | 2020-04-15 |
Proprietary Names
Many
Advantage Medical
Covidein
Reprocessed Fall Prevention Sensor
Aircast Venaflow
HoverMatt AirPal
Nellcor All Types
I.V.
MULTIPLE MODELS
REPROCESSED PRESSURE INFUSER
Masimo LNCS
Tourniquet,Pneumatic
Zimmer
Vasopress CTC
Nellcor OxiMax
Reprocessed TRP Compression Garment
ALP
Establishment Types
Reprocess Single-Use Device
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198