Datrend 8000-440

GUDID B418PHASE380004400

Phase3 is the first Defibrillator / Pacer Analyzer specifically designed to test Pulsed Multiphasic defibrillators. – tests Monophasic, Biphasic and P

Datrend Systems Inc

External defibrillator tester
Primary Device IDB418PHASE380004400
NIH Device Record Key976bd78c-bb0f-4295-b195-20205f049bb7
Commercial Distribution StatusIn Commercial Distribution
Brand NameDatrend
Version Model NumberPhase3
Catalog Number8000-440
Company DUNS249968140
Company NameDatrend Systems Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone604-291-7747
Emailcustomerservice@datrend.com
Phone604-291-7747
Emailcustomerservice@datrend.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB418PHASE380004400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRLTester, Defibrillator

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-08-18

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