ZOLL ECG Analysis Software

GUDID 00855778005333

ZOLL MANUFACTURING CORPORATION

Electrocardiograph, professional, multichannel
Primary Device ID00855778005333
NIH Device Record Keyed67ea5e-30a1-4c34-ba0a-16eb9b96da6c
Commercial Distribution StatusIn Commercial Distribution
Brand NameZOLL ECG Analysis Software
Version Model NumberVersion 1.0
Company DUNS079320559
Company NameZOLL MANUFACTURING 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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100855778005333 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DPSElectrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-30
Device Publish Date2019-04-22

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