Impulse 4000

Primary DI
00850540007133
Brand
Impulse 4000
Company
FLUKE ELECTRONICS CORPORATION
Model
IMPULSE4K-USA120V
Catalog number
2247157
Device description
Defibrillator/Pacer Analyzer
Published
2018-05-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DRLTester, Defibrillator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRLTester, DefibrillatorCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K941404000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K941404000IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZERHogan & Hartson1994-06-29DRL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850540007133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850540007133008505400071338505400071330850540007133

GMDN Terms#

Term, Definition table
TermDefinition
External defibrillator testerAn electronic instrument used to test an external defibrillator to ensure compliance with performance specifications. The device connects to the output of the defibrillator, typically via contact plates, and measures the energy delivered by the defibrillator into a standard resistive load; it may also perform transcutaneous pacemaker testing, provide waveform information, and execute other quality control procedures. The device may be used to test the function of an external defibrillator periodically, after repair, or for training purposes.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius35 Degrees Celsius
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002687614
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00850540007034ESA 615ESA615-10-NA22041321642018-05-24
00850540007041ESA 612ESA612-US41321732018-05-24
00850540007058ESA 612ESA612-10-NA22041322602018-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B3356600Defibrillator / Transcutaneous Pacemaker AnalyzerNETECH CORPORATIONDRL2020-03-05
00850540007119Impulse 6000DFLUKE ELECTRONICS CORPORATIONDRL2018-05-24
00850540007126Impulse 7000DPFLUKE ELECTRONICS CORPORATIONDRL2018-05-24
00850540007140Impulse 7010FLUKE ELECTRONICS CORPORATIONDRL2018-05-24
B418PHASE380004400DatrendDatrend Systems IncDRL2017-08-18
B3356500Defibrillator AnalyzerNETECH CORPORATIONDRL2017-06-16
B223011403ZAP GUARDGUARDIAN ANGEL PRODUCTS INCDRL2017-03-14
B22391766ZAP GUARDGUARDIAN ANGEL PRODUCTS INCDRL2017-03-14
00863313000309BC Biomedical Defibrillator AnalyzerBC GROUP INTERNATIONAL, INC.DRL2016-09-24
00863313000316BC Biomedical Defibrillator AnalyzerBC GROUP INTERNATIONAL, INC.DRL2016-09-24
00863313000323BC Biomedical Defibrillator Analyzer Variable LoadBC GROUP INTERNATIONAL, INC.DRL2016-09-24
00863313000330Gossen Metrawatt SECULIFEBC GROUP INTERNATIONAL, INC.DRL2016-09-24
00863313000347Gossen Metrawatt SECULIFEBC GROUP INTERNATIONAL, INC.DRL2016-09-24
00863313000354Gossen Metrawatt SECULIFEBC GROUP INTERNATIONAL, INC.DRL2016-09-24