ZENIX

GUDID 00847946033965

CABLE, ECG 3 LEAD SET, IEC

Zoll Medical Corporation

Electrocardiographic electrode, reusable
Primary Device ID00847946033965
NIH Device Record Key6c8409c0-dff3-4353-ae61-77a5af2d089f
Commercial Distribution StatusIn Commercial Distribution
Brand NameZENIX
Version Model Number9500-000628-12
Company DUNS055363428
Company NameZoll Medical Corporation
Device Count1
DM Exempttrue
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 HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0

Device Identifiers

Device Issuing AgencyDevice ID
GS100847946033965 [Primary]

FDA Product Code

MKJAutomated external defibrillators (non-wearable)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-21
Device Publish Date2024-11-13

On-Brand Devices [ZENIX]

00847946046989CABLE, ECG RIGHT ANGLE LIMB LEAD SET, 12 LEAD, IEC, THOR
00847946046972CABLE, ECG RIGHT ANGLE LIMB LEAD SET, 12 LEAD, AAMI, THOR
00847946047016ASSY, CABLE, ECG, 12 LEAD, NON-DETACHABLE, IEC, THOR
00847946046996ASSY, CABLE, ECG, 12 LEAD, NON-DETACHABLE, AAMI, THOR
00847946033965CABLE, ECG 3 LEAD SET, IEC
00847946056094CABLE, LIMB LEAD ECG, IEC

Trademark Results [ZENIX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ZENIX
ZENIX
98505403 not registered Live/Pending
Zenix Solutions, LLC
2024-04-17
ZENIX
ZENIX
90799500 not registered Live/Pending
ZOLL Medical Corporation
2021-06-28
ZENIX
ZENIX
85546795 4213680 Live/Registered
Sepax Technologies, Inc
2012-02-18
ZENIX
ZENIX
85316567 4165709 Live/Registered
Solenis Technologies, L.P.
2011-05-10
ZENIX
ZENIX
79208593 5658388 Live/Registered
KARATAS KOZMETIK KIMYA SAN. VE TIC. A.S.
2016-12-19
ZENIX
ZENIX
79088020 3988066 Live/Registered
ARC INTERNATIONAL
2010-06-29
ZENIX
ZENIX
79040686 3462608 Dead/Cancelled
The Royal Bank of Scotland Group plc
2007-06-01
ZENIX
ZENIX
78196070 not registered Dead/Abandoned
aaiPharma, Inc.
2002-12-19
ZENIX
ZENIX
77823530 3872117 Live/Registered
ARC MANAGEMENT & SERVICES
2009-09-10
ZENIX
ZENIX
77156163 not registered Dead/Abandoned
TransCardiac Therapeutics
2007-04-13
ZENIX
ZENIX
77110645 not registered Dead/Abandoned
Hercules Incorporated
2007-02-19
ZENIX
ZENIX
76161615 2626255 Dead/Cancelled
Hercules Incorporated
2000-11-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.