Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3036108847

FEI Number

3036108847

Entity Name

Solventum US LLC

City/State/Country

Eden Prairie, MN, US

Establishment Address

10351 West 70th Street, Eden Prairie, MN 55344, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Solventum US LLC (Owner Number: 10091183)

Owner / Operator Contact Address

12930 IH 10 West, San Antonio, TX 78249, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K060939

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2025-02-12
BSB	Warmer, Blood, Non-Electromagnetic Radiation	Hematology	Class 2	864.9205	2013-01-17
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2013-01-17
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2013-01-17
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2013-01-17

Official Correspondent

JEFFERY SCHORR

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Solventum US LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004943440	3M Purification, S. de R.L. de C. V.	San Luis Potosi Mexico, MX
3003775292	KCI POLYMEDICS BV	PEER Limburg, BE
3038988287	Solventum Canada Limited	Morden Manitoba, CA
3032763783	Solventum Poland Manufacturing SP. ZO.O	Wroclaw Dolnoslaskie, PL
3014209526	KCI NORTH IX (Technical Services Center)	San Antonio, TX, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K090508	Belmont Instrument Corp.	THE BELMONT BUDDY LITE FLUID WARMER	2009-03-26
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2010	Cincinnati Sub-Zero Products Inc	2	WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warming patients before, during and after surgery, and other specialty procedures.

Similar Registrations

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3011642792	Merit Maquiladora Mexico, S. DE R.L. DE C.V.	Tijuana Baja California, MX
1061124	Sterigenics U.S., LLC	Charlotte, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3036108847. Last updated year: 2026. Please use registration number 3036108847 when referencing this establishment in official correspondence.