FDA.reportPublic FDA data

CMP 200 DR

Primary DI
08853100000072
Brand
CMP 200 DR
Company
Communications & Power Industries Canada Inc
Model
VZW2556RC3
Device description
Generator, High-Voltage, X-Ray, Diagnostic ,CMP200, RAD, 65kW, 480V
Published
2020-07-24
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
08853100000072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08853100000072088531000000728853100000072

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height24.3Inch
Length25.7Inch
Width13.7Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure525 Millimeter of Mercury795 Millimeter of Mercury
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
202887311
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
false
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
00885310000038CMP 200 DRVZW2556RB2NA2020-07-24
00885310000045CMP200 DRVZW2556RB32020-07-24
00885310000052CMP 200 DRVZW2556RB42020-07-24
00885310000069CMP 200 DRVZW2556RC22020-07-24
00885310000076CMP 200 DRVZW2556RC32020-07-24
00885310000083CMP 200 DRVZW2556RD22020-07-24
00885310000090CMP 200 DRVZW2556RD32020-07-24
00885310000106CMP 200 DRVZW2556RE22020-07-24
00885310000113CMP 200 DRVZW2556RE32020-07-24
00885310000120CMP 200 DRVZW2556RE42020-07-24
00885310000137CMP 200 DRVZW2556RE52020-07-24
00885310000144CMP 200 DRVZW2556RH22020-07-24
00885310000151CMP 200 DRVZW2556RH32020-07-24
00885310000168CMP 200 DRVZW2556RH42020-07-24
00885310000175CMP 200 DRVZW2556RH52020-07-24
00885310000229Indico IQVZW2558FB22020-07-24
00885310000236Indico IQVZW2558FB32020-07-24
00885310000243Indico IQVZW2558FB82020-07-24
00885310000250Indico IQVZW2558FC22020-07-24
00885310000267Indico IQVZW2558FC32020-07-24

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