FDA.reportPublic FDA data

CURIUM

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#

OCTREOSCAN

Curium US LLC

Indium In -111 Pentetreotide

Ultratag

Curium US LLC

Kit for the Preparation of Technetium Tc 99m Red Blood Cells

Pulmotech MAA

Curium US LLC

kit for the preparation of technetium Tc 99m albumin aggregated

Applications#

GUDID#