FDA.reportPublic FDA data

Curium US LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30113538451946929Curium US LLC1N2026-01-012703 Wagner Pl Maryland Heights MO US 63043

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00369945000002Xenotron - Xenon (Xe 133) Gas Dispenser+1(866)789-2211pvnorthamerica@curiumpharma.com
00369945000019Ultravent - Ultravent Radioaerosol Delivery System+1(866)789-2211pvnorthamerica@curiumpharma.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1931621920818885K843640XENON XE 127/XE 133 GAS DISPENSERIYT1985-01-14
1931621379947710K822625SYNTEVENT ATOMIZER/NEBULIZER AEROSOLCCQ1982-10-13
1931621998255431

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYT21985-01-14
CCQ11982-10-13

NDC#

GUDID#