BC Biomedical Defibrillator Analyzer DA-2006P

GUDID 00863313000316

Defibrillator Analyzer, with Transcutaneous Pacemaker Input

BC GROUP INTERNATIONAL, INC.

External defibrillator tester
Primary Device ID00863313000316
NIH Device Record Keycfe5339b-bf37-469c-a9a0-1cb85b4400ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameBC Biomedical Defibrillator Analyzer
Version Model NumberDA-2006P
Catalog NumberDA-2006P
Company DUNS602930208
Company NameBC GROUP INTERNATIONAL, 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

Phone(314) 638-3800
Emailsales@bcgroupintl.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100863313000316 [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 Date2016-09-24

On-Brand Devices [BC Biomedical Defibrillator Analyzer]

00863313000316Defibrillator Analyzer, with Transcutaneous Pacemaker Input
00863313000309Defibrillator Analyzer, without Transcutaneous Pacemaker Input

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