ONESTEP

GUDID 00847946021238

ONESTEP PACING ELECTRODE, FC, SINGLE

BIO-DETEK INCORPORATED

Rechargeable professional automated external defibrillator
Primary Device ID00847946021238
NIH Device Record Key36fbd0b3-9e3a-4781-ae1e-5278a8f029e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameONESTEP
Version Model Number8900-000418-01
Company DUNS144116225
Company NameBIO-DETEK INCORPORATED
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 Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
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
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
GS100847946021238 [Primary]
GS110847946021235 [Package]
Package: [8 Units]
In Commercial Distribution

FDA Product Code

MKJAutomated external defibrillators (non-wearable)

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 Date2016-08-03

On-Brand Devices [ONESTEP]

00847946021238ONESTEP PACING ELECTRODE, FC, SINGLE
00847946021221ONESTEP CPR COMPLETE ELECTRODE, FC, SINGLE
00847946021160ONESTEP CPR COMPLETE ADULT/CHILD ELECTRODE, SINGLE
00847946016272ELECTRODES, ONESTEP COMPLETE, SINGLE, R SERIES
00847946016265ELECTRODES, ONESTEP CPR, SINGLE, R SERIES
00847946016258ELECTRODES, ONESTEP PACING, SINGLE, R SERIES
00847946016241ELECTRODES, ONESTEP BASIC, SINGLE, R SERIES

Trademark Results [ONESTEP]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ONESTEP
ONESTEP
98490946 not registered Live/Pending
ZUBAIR YOUSAF
2024-04-10
ONESTEP
ONESTEP
87814465 not registered Dead/Abandoned
Edward J. Noble
2018-02-28
ONESTEP
ONESTEP
87730984 not registered Live/Pending
Interplastic Corporation
2017-12-21
ONESTEP
ONESTEP
87610297 5452194 Live/Registered
Lumry, Christopher
2017-09-15
ONESTEP
ONESTEP
87542423 not registered Live/Pending
PLR IP Holdings, LLC
2017-07-25
ONESTEP
ONESTEP
87542387 not registered Live/Pending
PLR IP Holdings, LLC
2017-07-25
ONESTEP
ONESTEP
87041734 5320204 Live/Registered
Standard Textile Co., Inc.
2016-05-18
ONESTEP
ONESTEP
86014406 not registered Dead/Abandoned
Noble Ideas II, LLC
2013-07-18
ONESTEP
ONESTEP
85849717 4531803 Live/Registered
MOLECULAR DEVICES, LLC
2013-02-14
ONESTEP
ONESTEP
85149370 4270488 Dead/Cancelled
Beam, Longest & Neff, L.L.C.
2010-10-11
ONESTEP
ONESTEP
78765490 3198418 Live/Registered
LSC COMMUNICATIONS US, LLC
2005-12-02
ONESTEP
ONESTEP
78620120 not registered Dead/Abandoned
GMAC MORTGAGE LLC
2005-04-29

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