ZOLL BATTERY LI-ION

GUDID 00847946016784

Zoll Medical Corporation

Rechargeable professional automated external defibrillator
Primary Device ID00847946016784
NIH Device Record Key5ba82ce9-9f4c-4f4f-942e-50b014805983
Commercial Distribution StatusIn Commercial Distribution
Brand NameZOLL BATTERY LI-ION
Version Model Number1009-001535-03
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 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

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
GS100847946016784 [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 BATTERY LI-ION]

008479460994801017-001100-01
008479460168381008-002003-30
008479460168211008-002003-01
008479460167841009-001535-03
008479460167081017-001100-01
00847946049881BATTERY, LITHIUM ION, SUREPOWER II RECONDITIONED
00847946049898BATTERY, LI-ION 9 CELL 18650, RECONDITIONED

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