FDA.reportPublic FDA data

NA

Primary DI
00840682146395
Brand
NA
Company
GE Medical Systems, L.L.C.
Model
5801659-3
Device description
ECG Patient Cable
Published
2019-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Product Codes#

Code, Name table
CodeName
IXOSynchronizer, ECG / respirator, radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXOSynchronizer, Ecg / Respirator, RadiographicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682146395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682146395008406821463958406821463950840682146395

GMDN Terms#

Term, Definition table
TermDefinition
MRI system synchronizerA physiological monitoring unit used as a component of a diagnostic magnetic resonance imaging (MRI) system, 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 MRI applications. It is sometimes referred to as a gated imaging accessory or trigger.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
160032025
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682138796Revolution160mm Detector Upgrade2018-01-11
00198953085950PhotonovaSpectra5590000-502026-05-11
00198953081839NA6265300-602026-04-02
00198953081877NA6265300-622026-04-02
00840682120784Flashpad HD25302017-07-28
00840682120807Flashpad HD35432017-07-28
00840682103053DiscoveryPETCT 6102016-08-01
00840682143974O560 to 610 Upgrade5607000-22018-12-05
00840682145749OptimaXR240amx HD Upgrade Gen22019-07-15
10840682142875Discovery PET CT690 VCT Boost Upgrade2018-11-16
00840682102490RevolutionDiscovery CT2016-06-08
00840682102995DiscoveryPETCT 7102016-08-01
00840682103107DiscoveryIQ2016-08-01
00840682104364Definium50002016-08-01
00840682108218DiscoveryMI2016-10-11
00840682115261OptimaXR220amx2016-08-01
00840682115278OptimaXR200amx2016-08-01
00840682119238Precision500D2016-08-01
00840682119658NA54216982016-08-01
00840682120975DiscoveryMI Digital Ready2016-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00855170007447Pneumograph - Non-Metallic 98in. TubingLAFAYETTE INSTRUMENT COMPANY, INC.IXO2025-08-14
00855170007140PNEUMO NONMETALIC 10' LATEX FREELAFAYETTE INSTRUMENT COMPANY, INC.IXO2023-06-12
00855170007157PED NONMETAL PNEUMO 10' LATEX FREELAFAYETTE INSTRUMENT COMPANY, INC.IXO2023-06-12
00855170007164NONMETAL PNEUMO 12' LUER LATEX FREELAFAYETTE INSTRUMENT COMPANY, INC.IXO2023-06-12
00855170007195"PNEUMO NONMETALIC 89"" LATEX FREE"LAFAYETTE INSTRUMENT COMPANY, INC.IXO2023-06-12
00855170007201"PED NONMETAL PNEUMO 89"" LATEX FREE"LAFAYETTE INSTRUMENT COMPANY, INC.IXO2023-06-12
00855170007270Pneumograph - Non-Metallic 10ft. TubingLAFAYETTE INSTRUMENT COMPANY, INC.IXO2021-08-31
00855170007287Pediatric Pneumograph - Non-Metallic w/10' TubingLAFAYETTE INSTRUMENT COMPANY, INC.IXO2021-08-31
00855170007294Pneumograph - Non-Metallic 12' w/ConnectorLAFAYETTE INSTRUMENT COMPANY, INC.IXO2021-08-31
00855170007300Pneumograph - Non-Metallic 14ft. TubingLAFAYETTE INSTRUMENT COMPANY, INC.IXO2021-08-31
00855170007317Pneumograph - Non-Metallic 18' w/ConnectorLAFAYETTE INSTRUMENT COMPANY, INC.IXO2021-08-31
00855170007324Pneumograph - Non-Metallic 89in. TubingLAFAYETTE INSTRUMENT COMPANY, INC.IXO2021-08-31
00855170007331"Pediatric Pneumograph - Non-Metallic w/89"" Tubing"LAFAYETTE INSTRUMENT COMPANY, INC.IXO2021-08-31
00855170007348Pneumograph Nonmetalic 135cm StrapLAFAYETTE INSTRUMENT COMPANY, INC.IXO2021-08-31
00816396020788CTM-400IVY BIOMEDICAL SYSTEMS, INC.IXO2016-11-10
00816396020795CTM-400IVY BIOMEDICAL SYSTEMS, INC.IXO2016-11-10
00816396020801CTM-400IVY BIOMEDICAL SYSTEMS, INC.IXO2016-11-10
00816396022171CTM-400IVY BIOMEDICAL SYSTEMS, INC.IXO2016-11-10