Solventum US LLC

FDA Device Registration & Listing · Flemington, NJ, US · Registration 3036504234

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3036504234
FEI Number
3036504234
Entity Name
Solventum US LLC
City/State/Country
Flemington, NJ, US
Establishment Address
500 Rt. 202 North, Flemington, NJ 08822, 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
N
Expiration Date (Year)
2026
510(k) Number
K220942
PMA Number
N/A

All Registered Proprietary Names

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Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LXZ Guard, Instrument General, Plastic Surgery Class 1 878.4800 2007-12-05
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-06-23
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2007-12-05
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2007-12-05
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 1997-02-20
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2007-12-05
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2007-12-05
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2010-01-27
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2007-12-05
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-06-16
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2007-12-05
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2022-09-06

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
3036108847 Solventum US LLC Eden Prairie, MN, US
3038988287 Solventum Canada Limited Morden Manitoba, CA
3032763783 Solventum Poland Manufacturing SP. ZO.O Wroclaw Dolnoslaskie, PL

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K151482 Bcr Diagnostics, Inc. BCR-30-min BI™ and RBIP-ST30™ Readout Accessory 2016-02-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2007 N/A 2
3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3036504234. Last updated year: 2026. Please use registration number 3036504234 when referencing this establishment in official correspondence.
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