Datrend

Primary DI
B418PHASE380004400
Brand
Datrend
Company
Datrend Systems Inc
Model
Phase3
Catalog number
8000-440
Device description
Phase3 is the first Defibrillator / Pacer Analyzer specifically designed to test Pulsed Multiphasic defibrillators.– tests Monophasic, Biphasic and Pulsed Multiphasic Defibrillators, AEDs and Transcutaneous Pacers– see www.datrend.com for complete information
Published
2017-08-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRLTester, Defibrillator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRLTester, DefibrillatorCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062099000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062099000PHASE 3, MODEL DT-1Datrend Systems, Inc.2007-01-25DRL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B418PHASE380004400PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
604-291-7747customerservice@datrend.com

Regulatory Flags#

DUNS number
249968140
Device count
1
Serial number
true

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
00850540007133Impulse 4000FLUKE ELECTRONICS CORPORATIONDRL2018-05-24
00850540007140Impulse 7010FLUKE ELECTRONICS CORPORATIONDRL2018-05-24
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