BIO-DETEK MFE

GUDID 00847946018412

ELECTRODE ASSEMBLY BIO-DETEK PRECONNECT MFE ZOLL CON COMMODITY STYLE - SINGLE

BIO-DETEK INCORPORATED

Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator
Primary Device ID00847946018412
NIH Device Record Keya4900ea9-8f88-4da3-ac31-adae6bf5bda1
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIO-DETEK MFE
Version Model NumberAD-2023-0001
Company DUNS144116225
Company NameBIO-DETEK INCORPORATED
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100847946018412 [Primary]
GS110847946018419 [Package]
Package: CASE [10 Units]
In Commercial Distribution

FDA Product Code

LDDDc-Defibrillator, Low-Energy, (Including Paddles)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2014-09-23

On-Brand Devices [BIO-DETEK MFE]

00847946018429AD-2023-0002
00847946018412ELECTRODE ASSEMBLY BIO-DETEK PRECONNECT MFE ZOLL CON COMMODITY STYLE - SINGLE
00847946018405ELECTRODE ASSEMBLY BIO-DETEK PRECONNECT MFE PHYSIO CON - SINGLE

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