Home GUDID 00816396020801 CTM-400
Primary DI 00816396020801
Brand CTM-400
Company IVY BIOMEDICAL SYSTEMS, INC.
Model 3310-02-15
Catalog number 3310-02-15
Device description Cardiac Gating Module & Accessory Kit
Published 2016-11-10
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true Product Codes# Code, Name table Code Name IXO Synchronizer, Ecg/Respirator, Radiographic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class IXO Synchronizer, Ecg / Respirator, Radiographic Radiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816396020801 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00816396020801 00816396020801 816396020801 0816396020801
GMDN Terms# Term, Definition table Term Definition X-ray system synchronizer A physiological monitoring unit used as a component of a diagnostic x-ray system, e.g., fluoroscopy, angiography or general-purpose, that produces a signal which enables image formation or data collection to be synchronized with a specific measurable physiological parameter, e.g., the beginning of a patient's respiratory or cardiac cycle. It is primarily used for the purpose of artifact reduction or enhancement of signal-to-noise ratios in various real-time or dynamic diagnostic x-ray applications. It is sometimes referred to as a gated imaging accessory or trigger.
Device Sizes# Type, Value, Unit table Type Value Unit Depth 11 Inch Height 2 Inch Weight 1.25 Pound Width 4 Inch
Regulatory Flags# DUNS number 109132019 Device count 1 Premarket exempt true Combination product true Serial number true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00855170007447 Pneumograph - Non-Metallic 98in. Tubing LAFAYETTE INSTRUMENT COMPANY, INC. IXO 2025-08-14 00855170007140 PNEUMO NONMETALIC 10' LATEX FREE LAFAYETTE INSTRUMENT COMPANY, INC. IXO 2023-06-12 00855170007157 PED NONMETAL PNEUMO 10' LATEX FREE LAFAYETTE INSTRUMENT COMPANY, INC. IXO 2023-06-12 00855170007164 NONMETAL PNEUMO 12' LUER LATEX FREE LAFAYETTE INSTRUMENT COMPANY, INC. IXO 2023-06-12 00855170007195 "PNEUMO NONMETALIC 89"" LATEX FREE" LAFAYETTE INSTRUMENT COMPANY, INC. IXO 2023-06-12 00855170007201 "PED NONMETAL PNEUMO 89"" LATEX FREE" LAFAYETTE INSTRUMENT COMPANY, INC. IXO 2023-06-12 00855170007270 Pneumograph - Non-Metallic 10ft. Tubing LAFAYETTE INSTRUMENT COMPANY, INC. IXO 2021-08-31 00855170007287 Pediatric Pneumograph - Non-Metallic w/10' Tubing LAFAYETTE INSTRUMENT COMPANY, INC. IXO 2021-08-31 00855170007294 Pneumograph - Non-Metallic 12' w/Connector LAFAYETTE INSTRUMENT COMPANY, INC. IXO 2021-08-31 00855170007300 Pneumograph - Non-Metallic 14ft. Tubing LAFAYETTE INSTRUMENT COMPANY, INC. IXO 2021-08-31 00855170007317 Pneumograph - Non-Metallic 18' w/Connector LAFAYETTE INSTRUMENT COMPANY, INC. IXO 2021-08-31 00855170007324 Pneumograph - Non-Metallic 89in. Tubing LAFAYETTE INSTRUMENT COMPANY, INC. IXO 2021-08-31 00855170007331 "Pediatric Pneumograph - Non-Metallic w/89"" Tubing" LAFAYETTE INSTRUMENT COMPANY, INC. IXO 2021-08-31 00855170007348 Pneumograph Nonmetalic 135cm Strap LAFAYETTE INSTRUMENT COMPANY, INC. IXO 2021-08-31 00840682146395 NA GE Medical Systems, L.L.C. IXO 2019-09-20 00816396020788 CTM-400 IVY BIOMEDICAL SYSTEMS, INC. IXO 2016-11-10 00816396020795 CTM-400 IVY BIOMEDICAL SYSTEMS, INC. IXO 2016-11-10 00816396022171 CTM-400 IVY BIOMEDICAL SYSTEMS, INC. IXO 2016-11-10
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