FDA.reportPublic FDA data

ESA 615

Primary DI
00850540007034
Brand
ESA 615
Company
FLUKE ELECTRONICS CORPORATION
Model
ESA615-10-NA220
Catalog number
4132164
Device description
Electrical Safety Analyzer
Published
2018-05-24
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
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850540007034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850540007034008505400070348505400070340850540007034

GMDN Terms#

Term, Definition table
TermDefinition
Electrical safety testerAn instrument designed to manually and/or automatically verify the safety of electrically-powered medical devices. It typically includes an electric current meter that can measure the alternating current (AC) and direct current (DC) in micro- and mili-amperes with a frequency response that complies with appropriate standards. The device can perform AC and DC leakage-current measurements (typically in the range of 1 A to 20 mA) and resistance-to-ground assessments using two- and/or four-terminal techniques in devices up to several ohms; it may also perform patient lead isolation tests in multiple-electrode devices.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002687614
Device count
1
DM exempt
false
Premarket exempt
false
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
00850540007133Impulse 4000IMPULSE4K-USA120V22471572018-05-24
00850540007157SigmaPace 1000SIGMAP1K-USA120V22477002018-05-24
00850540007188DPM1BDPM1B22497792018-05-24
00850540007225ProSim 8PPROSIM 8P60217062025-05-07
00850540007195BP Pump 2LBPPUMP2L-US120V22490362018-05-24
00850540007201BP Pump 2MBPPUMP2M-US120V22490492018-05-24
00850540007218ESA 614ESA61450319182019-04-04
00850540007065ProSim 8PROSIM 839794092018-05-24
00850540007072ProSim 4PROSIM 439851562018-05-24
00850540007089ProSim 2PROSIM 243183412018-05-24
00850540007096ProSim 3PROSIM 343077902018-05-24
00850540007102ProSim SPOT LightSPOT LIGHT41111012018-05-24
00850540007119Impulse 6000DIMPULSE 6000D28119282018-05-24
00850540007140Impulse 7010IMPULSE 701031585442018-05-24
00850540007164PS320PS32025830302018-05-24
00850540007171PS410PS41026312762018-05-24
00850540007010ESA 620ESA62027857252018-05-24
00850540007027ESA 615ESA615-US41320462018-05-24
00850540007041ESA 612ESA612-US41321732018-05-24
00850540007058ESA 612ESA612-10-NA22041322602018-05-24

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