Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034520

FEI Number

3003350313

Entity Name

RENU MEDICAL, INC.

City/State/Country

EVERETT, WA, US

Establishment Address

5900 36th Ave W Ste 100, EVERETT, WA 98203, US

Establishment Type(s)

Reprocess Single-Use Device,Repack or Relabel Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

RENU MEDICAL, INC. (Owner Number: 9046359)

Owner / Operator Contact Address

5900 36th Ave West, Bldg B, Suite 100, Everett, WA 98203, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K111773

PMA Number

N/A

All Registered 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 Nellcor All Types Tourniquet,Pneumatic Zimmer Vasopress CTC Nellcor OxiMax

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2007-12-04
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2014-12-03
KMI	Monitor, Bed Patient	General Hospital	Class 1	880.2400	2022-07-21
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2016-05-26
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2016-04-18
NLF	Oximeter, Reprocessed	Cardiovascular	Class 2	870.2700	2007-12-04
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2004-11-17
NLF	Oximeter, Reprocessed	Cardiovascular	Class 2	870.2700	2016-05-05
NLF	Oximeter, Reprocessed	Cardiovascular	Class 2	870.2700	2007-12-04
KCY	Tourniquet, Pneumatic	General, Plastic Surgery	Class 1	878.5910	2008-05-30
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2020-04-15
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2016-05-26
NLF	Oximeter, Reprocessed	Cardiovascular	Class 2	870.2700	2016-05-05

Official Correspondent

John Petrush

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RENU MEDICAL, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K170216	Tactile Systems Technology, Inc. (Dba Tactile Medical)	Flexitouch System	2017-05-26
K100306	Covidien	KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES	2010-05-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2018	Handicare Usa Inc	1	PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Z-0014-2018	Handicare AB Maskinvagen	1	Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009

Similar Registrations

Registration Number	Establishment Name	Location
3033981998	KOYA MEDICAL, INC.	Dallas, TX, US
3020703724	Therma Bright Inc.	Toronto Ontario, CA
3014491159	AIROS MEDICAL INC	Audubon, PA, US
3014834638	ZENITH TECHNICAL INNOVATIONS, LLC	Gurnee, IL, US
3009155917	GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034520. Last updated year: 2026. Please use registration number 3034520 when referencing this establishment in official correspondence.