System, Rebreathing, Radionuclide

Product Code: IYT

Radiology Radioisotope Therapy Devices

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 892.1390


Radiation TypeIonizing
Radition SafetyNone
Annual ReportsNo

Products Classified as IYT

5332System, Rebreathing, RadionuclideRadionuclide Rebreathing System.

Total Product Life Cycle (TPLC) Devices

5332System, Rebreathing, RadionuclideRadionuclide Rebreathing System.

Pre-market Notifications for IYT

K953513XENON CIRCUITKING SYSTEMS CORP.
K952223XENON GAS BREATHING CIRCUITINTERTECH RESOURCES, INC.
K914747XENON CIRCUITGIBECK, INC.
K913416TETLEY PATIENT ADMINISTRATION SETTETLEY MEDICAL LTD.
K912626BOLUS XENON CIRCUITVITAL SIGNS, INC.
K903694AMICI TRU-FIT SOFT PLASTIC MOUTHPIECEAMICI, INC.
K904684AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATIONAMICI, INC.
K903805AMICI XENON ADMINISTRATION SETAMICI, INC.
K896885DISPOSABLE RESPIRTORY KIT (MP-200)MEDIPART JERRY ALEXANDER
K896475DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELDMEDIPART JERRY ALEXANDER
K896476DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELDMEDIPART JERRY ALEXANDER
K896124MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133MEDIPART JERRY ALEXANDER
K896125MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133MMEDIPART JERRY ALEXANDER
K881812AERO-MIST NEBULIZERCADEMA MEDICAL PRODUCTS, INC.
K872920AMICI KRYPTON ADMINISTRATION SYSTEM*AMICI, INC.

Global Unique Device Identification Database

00369945000002System, rebreathing, radionuclide
00612649169477System, rebreathing, radionuclide
00612649103600System, rebreathing, radionuclide
00612649103556System, rebreathing, radionuclide
00612649103532System, rebreathing, radionuclide
00612649103518System, rebreathing, radionuclide
00612649103426System, rebreathing, radionuclide
00612649131207System, rebreathing, radionuclide
00612649103396System, rebreathing, radionuclide
00612649171845System, rebreathing, radionuclide
00612649103372System, rebreathing, radionuclide
00612649102931System, rebreathing, radionuclide
00612649102924System, rebreathing, radionuclide
00612649102900System, rebreathing, radionuclide
00612649102894System, rebreathing, radionuclide

Maude Adverse Events

XENON PULMONEX IIBIODEX MEDICAL SYSTEMS, INC.2013-07-03
XENON PULMONEX IIBIODEX MEDICAL SYSTEMS INC.2013-05-15
VENTSCAN IV DISPOSABLEBIODEX2012-07-17
RAD SOURCE/RS 3000*2002-06-06
1998-10-21
PULMONEX XENON SYSTEMBIODEX MEDICAL SYSTEMS, INC.1998-09-22

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