FDA.reportPublic FDA data

Delta

Primary DI
14718018530107
Brand
Delta
Company
DELTA ELECTRONICS, INC. CHUNGLI 5 PLANT
Model
MDS-00010
Catalog number
DMP-100R
Published
2024-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IZOGenerator, High-Voltage, X-Ray, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZOGenerator, High-Voltage, X-Ray, DiagnosticRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14718018530107PackageGS11In Commercial Distribution
24718018530104PackageGS16In Commercial Distribution
04718018530100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471801853010714718018530107
2471801853010424718018530104
04718018530100047180185301004718018530100

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic x-ray system generator, stationaryA generator which is an integral component of a stationary diagnostic x-ray system, e.g., a system intended to be operated at a fixed location within a facility or mobile imaging van. It is used to regulate incoming voltage and current to provide an x-ray tube with the power needed to produce an x-ray beam of the desired voltage (kV) and current (mA). It typically comprises a control assembly (console) and high voltage transformer assembly, or it is of a mono-tank generator design and includes transformer, constant potential, inverter and capacitor discharge generator designs.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658698699
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04718018530124DeltaDMG-32KAX ADMP-100RF2024-06-03
04718018530131DeltaDMG-32KAX BDMP-100RF2024-06-03
04718018530148DeltaDMG-40KAX ADMP-100RF2024-06-03
04718018530155DeltaDMG-40KAX BDMP-100RF2024-06-03
04718018530162DeltaDMG-50KAX BDMP-100RF2024-06-03
04718018530179DeltaDMG-56KAX BDMP-100RF2024-06-03
04718018530186DeltaDMG-65KAX BDMP-100RF2024-06-03
04718018530193DeltaDMG-71KAX BDMP-100RF2024-06-03
04718018530209DeltaDMG-80KAX BDMP-100RF2024-06-03
04718018530216DeltaDMG-82KAX BDMP-100RF2024-06-03
14718018530121DeltaDMG-32KAX ADMP-100RF2024-06-03
14718018530138DeltaDMG-32KAX BDMP-100RF2024-06-03
14718018530145DeltaDMG-40KAX ADMP-100RF2024-06-03
14718018530152DeltaDMG-40KAX BDMP-100RF2024-06-03
14718018530169DeltaDMG-50KAX BDMP-100RF2024-06-03
14718018530176DeltaDMG-56KAX BDMP-100RF2024-06-03
14718018530183DeltaDMG-65KAX BDMP-100RF2024-06-03
14718018530190DeltaDMG-71KAX BDMP-100RF2024-06-03
14718018530206DeltaDMG-80KAX BDMP-100RF2024-06-03
14718018530213DeltaDMG-82KAX BDMP-100RF2024-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00055846500108Epsilon High Voltage GeneratorEMD TechnologiesIZO2026-01-12
00055846500115Epsilon High Voltage GeneratorEMD TechnologiesIZO2026-01-12
00055846500122Epsilon High Voltage GeneratorEMD TechnologiesIZO2026-01-12
08718755004106Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004113Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004144Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004168Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004182Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004199Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004205Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004212Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004243Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004120Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004137Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004151Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004175Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004229Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004236Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004250Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004090Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-17
06973858210492Medical X-ray High Frequency High Voltage GeneratorSuzhou Powersite Electric Co., LTDIZO2025-05-29
08800011110437DRGEMDRGEM CorporationIZO2025-05-28
08800011110444DRGEMDRGEM CorporationIZO2025-05-28
08800011110451DRGEMDRGEM CorporationIZO2025-05-28
08800011110468DRGEMDRGEM CorporationIZO2025-05-28
08800011110475DRGEMDRGEM CorporationIZO2025-05-28
08800011110482DRGEMDRGEM CorporationIZO2025-05-28
08800011110499DRGEMDRGEM CorporationIZO2025-05-28
08800011110505DRGEMDRGEM CorporationIZO2025-05-28
08800011110512DRGEMDRGEM CorporationIZO2025-05-28