FDA.reportPublic FDA data

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

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