PRO PADZ

GUDID 00847946021214

PRO-PADZ STERILE ADULT/CHILD W/10 FOOT (3M) LEADWIRES, SINGLE

BIO-DETEK INCORPORATED

Rechargeable professional automated external defibrillator
Primary Device ID00847946021214
NIH Device Record Keyd5622c27-221b-4972-8759-0599a8566cca
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRO PADZ
Version Model Number8900-000414-01
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

Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100847946021214 [Primary]
GS110847946021211 [Package]
Package: [6 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 [PRO PADZ]

00847946021214PRO-PADZ STERILE ADULT/CHILD W/10 FOOT (3M) LEADWIRES, SINGLE
00847946021207PRO-PADZ STERILE ADULT/CHILD ELECTRODE, SINGLE
00847946021191PRO-PADZ RADIOLUCENT SOLID GEL ADULT/CHILD ELECTRODE, SINGLE
00847946016661PRO*PADZ SOLID GEL RADIOLUCENT MULTI-FUNCTION ELECTRODES - 1 PAIR
00847946016487PRO PADZ STERILE MULTI-FUNCTION ELECTRODES WITH 10 FOOT LEAD WIRES - 1 PAIR
00847946016470PRO PADZ STERILE MULTI-FUNCTION ELECTRODES WITH 54 INCH LEAD WIRES - 1 PAIR
00847946016463PRO*PADZ SOLID GEL RADIOLUCENT MULTI-FUNCTION ELECTRODES - 1 PAIR
00847946016418PRO*PADZ BIPHASIC MULTI-FUNCTION ELECTRODES - 1 PAIR
00847946016401PRO-PADZ LIQUID GEL RADIOLUCENT MFE, 1 SET
00847946016395ELECTRODES, PRO-PADZ CARDIOLOGY W/LVP GEL, SINGLE
00847946001445PRO*PADZ PACING ONLY ADULT ELECTRODES - 1 PAIR

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