Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034521

FEI Number

3003350319

Entity Name

Radnostix

City/State/Country

IDAHO FALLS, ID, US

Establishment Address

4137 Commerce Cir, IDAHO FALLS, ID 83401, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

RADNOSTIX INC. (Owner Number: 9045407)

Owner / Operator Contact Address

4137 COMMERCE CIRCLE, --, Idaho Falls, ID 83401, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BM83 Ruler Series BMVQC BM10 Radvent Swirler Swirler The RadVent Swirler Nebulizer The Swirler Nebulizer The Swirler UltraShield BM68 Series BM01 Series BM05 Series BMNT57 Series BM55 Series BM04 Series BM83 Line Series BMCY68 Series BM22-01 BMSY-057 BM53 Series BM02 Series BM07 Series BMAN68 BM06 Series BM08 Series The RadVent Swirler Aerosol System The Swirler Aerosol System INIS-SF-X.X-YY-Z Series

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JAR	Phantom, Test-Pattern, Radionuclide	Radiology	Class 1	892.1420	2021-12-03
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2023-09-08
IWR	Holder, Syringe, Lead	Radiology	Class 1	892.6500	2023-12-06
IYQ	Phantom, Flood Source, Nuclear	Radiology	Class 1	892.1380	2001-04-04
IXD	Source, Calibration, Sealed, Nuclear	Radiology	Class 1	892.1400	2009-10-14
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2023-09-08
IWH	Source, Teletherapy, Radionuclide	Radiology	Class 1	892.5740	2009-10-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RADNOSTIX 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
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034521. Last updated year: 2026. Please use registration number 3034521 when referencing this establishment in official correspondence.