Gossen Metrawatt SECULIFE M695P

GUDID 00863313000347

Defibrillator Analyzer, with Transcutaneous Pacemaker Input - private labeled for Gossen Metrawatt

BC GROUP INTERNATIONAL, INC.

External defibrillator tester
Primary Device ID00863313000347
NIH Device Record Keyd2cdfb8b-3266-4501-8a6a-3b919bdb38ed
Commercial Distribution StatusIn Commercial Distribution
Brand NameGossen Metrawatt SECULIFE
Version Model NumberDF+
Catalog NumberM695P
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
GS100863313000347 [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 [Gossen Metrawatt SECULIFE]

00863313000354Defibrillator Analyzer, without Transcutaneous Pacemaker Input - private labeled for Gossen Metr
00863313000347Defibrillator Analyzer, with Transcutaneous Pacemaker Input - private labeled for Gossen Metrawa
00863313000330Defibrillator Analyzer Variable Load, for use with Seculife DF Base and Seculife DF+ - private l

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