ZOLL MFC

GUDID 00847946016777

Zoll Medical Corporation

Rechargeable professional automated external defibrillator
Primary Device ID00847946016777
NIH Device Record Key1429d9e7-63e4-4461-9d32-398698a3dee0
Commercial Distribution StatusIn Commercial Distribution
Brand NameZOLL MFC
Version Model Number1009-0913-03
Company DUNS055363428
Company NameZoll Medical Corporation
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100847946016777 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DROPACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

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 Date2014-09-24

On-Brand Devices [ZOLL MFC]

00847946099671CABLE ASSY, MFC-CPRD, X SERIES
008479460183201009-0913-05
008479460183131009-0913-04
008479460168071007-0196-01
008479460167771009-0913-03
008479460166921001-0196-02
00847946055998CABLE ASSY, MFC-CPRD, X SERIES

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