Pad-Pak PAD-PAK-07

GUDID 05060167124488

Battery and Electrode Cartridge

HEARTSINE TECHNOLOGIES LTD

Non-rechargeable public semi-automated external defibrillator electrode, adult Non-rechargeable public semi-automated external defibrillator electrode, adult Non-rechargeable public semi-automated external defibrillator electrode, adult Non-rechargeable public semi-automated external defibrillator electrode, adult Non-rechargeable public semi-automated external defibrillator electrode, adult Non-rechargeable public semi-automated external defibrillator electrode, adult Non-rechargeable public semi-automated external defibrillator electrode, adult Non-rechargeable public semi-automated external defibrillator electrode, adult Non-rechargeable public semi-automated external defibrillator electrode, adult Non-rechargeable public semi-automated external defibrillator electrode, adult Non-rechargeable public semi-automated external defibrillator electrode, adult Non-rechargeable public semi-automated external defibrillator electrode, adult Non-rechargeable public semi-automated external defibrillator electrode, adult Non-rechargeable public semi-automated external defibrillator electrode, adult Non-rechargeable public semi-automated external defibrillator electrode, adult Non-rechargeable public semi-automated external defibrillation electrode, adult Non-rechargeable public semi-automated external defibrillation electrode, adult Non-rechargeable public semi-automated external defibrillation electrode, adult Non-rechargeable public semi-automated external defibrillation electrode, adult Non-rechargeable public semi-automated external defibrillation electrode, adult Non-rechargeable public semi-automated external defibrillation electrode, adult Non-rechargeable public semi-automated external defibrillation electrode, adult Non-rechargeable public semi-automated external defibrillation electrode, adult Non-rechargeable public semi-automated external defibrillation electrode, adult Non-rechargeable public semi-automated external defibrillation electrode, adult Non-rechargeable public semi-automated external defibrillation electrode, adult Non-rechargeable public semi-automated external defibrillation electrode, adult Non-rechargeable public semi-automated external defibrillation electrode, adult Non-rechargeable public semi-automated external defibrillation electrode, adult Non-rechargeable public semi-automated external defibrillation electrode, adult
Primary Device ID05060167124488
NIH Device Record Key8a50d974-3a6e-48f3-83f6-ff20f7d11985
Commercial Distribution StatusIn Commercial Distribution
Brand NamePad-Pak
Version Model NumberPad-Pak-07
Catalog NumberPAD-PAK-07
Company DUNS230479318
Company NameHEARTSINE TECHNOLOGIES LTD
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(215)860-8100
Emailheartsinesupport@stryker.com
Phone+1(215)860-8100
Emailheartsinesupport@stryker.com
Phone+1(215)860-8100
Emailheartsinesupport@stryker.com
Phone+1(215)860-8100
Emailheartsinesupport@stryker.com
Phone+1(215)860-8100
Emailheartsinesupport@stryker.com
Phone+1(215)860-8100
Emailheartsinesupport@stryker.com
Phone+1(215)860-8100
Emailheartsinesupport@stryker.com
Phone+1(215)860-8100
Emailheartsinesupport@stryker.com
Phone+1(215)860-8100
Emailheartsinesupport@stryker.com
Phone+1(215)860-8100
Emailheartsinesupport@stryker.com
Phone+1(215)860-8100
Emailheartsinesupport@stryker.com
Phone+1(215)860-8100
Emailheartsinesupport@stryker.com
Phone+1(215)860-8100
Emailheartsinesupport@stryker.com
Phone+1(215)860-8100
Emailheartsinesupport@stryker.com
Phone+1(215)860-8100
Emailheartsinesupport@stryker.com
Phone+1(215)860-8100
Emailheartsinesupport@stryker.com
Phone+1(215)860-8100
Emailheartsinesupport@stryker.com
Phone+1(215)860-8100
Emailheartsinesupport@stryker.com
Phone+1(215)860-8100
Emailheartsinesupport@stryker.com
Phone+1(215)860-8100
Emailheartsinesupport@stryker.com
Phone+1(215)860-8100
Emailheartsinesupport@stryker.com
Phone+1(215)860-8100
Emailheartsinesupport@stryker.com
Phone+1(215)860-8100
Emailheartsinesupport@stryker.com
Phone+1(215)860-8100
Emailheartsinesupport@stryker.com
Phone+1(215)860-8100
Emailheartsinesupport@stryker.com
Phone+1(215)860-8100
Emailheartsinesupport@stryker.com
Phone+1(215)860-8100
Emailheartsinesupport@stryker.com
Phone+1(215)860-8100
Emailheartsinesupport@stryker.com
Phone+1(215)860-8100
Emailheartsinesupport@stryker.com
Phone+1(215)860-8100
Emailheartsinesupport@stryker.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS105060167124488 [Primary]
HIBCCM727PADPAK07 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2020-08-28
Device Publish Date2020-08-20

On-Brand Devices [Pad-Pak]

05060167124488Battery and Electrode Cartridge
M727PADPAK01Battery and Electrode Cartridge
M727PADPAK07Combined Battery and Electrode Cartridge. Accessory to a therapeutic medical device in the rang

Trademark Results [Pad-Pak]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PAD-PAK
PAD-PAK
73555541 1390766 Dead/Cancelled
PAD-PAK, INC.
1985-08-26
PAD-PAK
PAD-PAK
72257771 0842633 Dead/Expired
CLARK-CUTLER-MCDERMOTT COMPANY
1966-11-02

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