11131-000001

GUDID 00681490583275

ASSY,PADDLE,INTERNAL HANDLE,REPLACEMENT RESIN,CE

PHYSIO-CONTROL, INC.

Internal defibrillator electrode, adult
Primary Device ID00681490583275
NIH Device Record Key3d6373c9-f0a0-4696-8a1b-8fe26559a81d
Commercial Distribution StatusIn Commercial Distribution
Version Model Number11131
Catalog Number11131-000001
Company DUNS009251992
Company NamePHYSIO-CONTROL, INC.
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@physio-control.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@physio-control.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@physio-control.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@physio-control.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@physio-control.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@physio-control.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@physio-control.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@physio-control.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@physio-control.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@physio-control.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@physio-control.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@physio-control.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@physio-control.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@physio-control.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@physio-control.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100681490583275 [Primary]
GS100883873824702 [Primary]

FDA Product Code

LDDDc-defibrillator, low-energy, (including paddles)
MKJAutomated external defibrillators (non-wearable)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00681490583275]

Hydrogen Peroxide;Moist Heat or Steam Sterilization


[00681490583275]

Hydrogen Peroxide;Moist Heat or Steam Sterilization


[00681490583275]

Hydrogen Peroxide;Moist Heat or Steam Sterilization


[00681490583275]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00681490583275]

Hydrogen Peroxide;Moist Heat or Steam Sterilization


[00681490583275]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00681490583275]

Hydrogen Peroxide;Moist Heat or Steam Sterilization


[00681490583275]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00681490583275]

Hydrogen Peroxide;Moist Heat or Steam Sterilization


[00681490583275]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00681490583275]

Hydrogen Peroxide;Moist Heat or Steam Sterilization


[00681490583275]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00681490583275]

Hydrogen Peroxide;Moist Heat or Steam Sterilization


[00681490583275]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00681490583275]

Hydrogen Peroxide;Moist Heat or Steam Sterilization


[00681490583275]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00681490583275]

Hydrogen Peroxide;Moist Heat or Steam Sterilization


[00681490583275]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00681490583275]

Hydrogen Peroxide;Moist Heat or Steam Sterilization


[00681490583275]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00681490583275]

Hydrogen Peroxide;Moist Heat or Steam Sterilization


[00681490583275]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00681490583275]

Hydrogen Peroxide;Moist Heat or Steam Sterilization


[00681490583275]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00681490583275]

Hydrogen Peroxide;Moist Heat or Steam Sterilization


[00681490583275]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00681490583275]

Hydrogen Peroxide;Moist Heat or Steam Sterilization


[00681490583275]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00681490583275]

Hydrogen Peroxide;Moist Heat or Steam Sterilization


[00681490583275]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00681490583275]

Hydrogen Peroxide;Moist Heat or Steam Sterilization


[00681490583275]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-24
Device Publish Date2019-09-16

Devices Manufactured by PHYSIO-CONTROL, INC.

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00883873761441 - PEDIATRIC PADDLE, EXTERNAL2024-11-18 ASSY PEDIATRIC PADDLE,MULTI LANGUAGE, 3RD EDT
00883873777466 - LIFEPAK 15 MONITOR/DEFIBRILLATOR2024-11-18 15AABAAABABBBABAAAAAAABFLP15 MONITOR/DEFIB
00883873907252 - NA2024-10-28 CABLE-ADAPTER,LP15 INTERNAL PADDLES,ROHS,3RD EDT
00883873761533 - LIFEPAK 35 Monitor/Defibrillator2024-09-12 LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,IP-TEMP,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
00883873761540 - LIFEPAK 35 Monitor/Defibrillator2024-09-12 LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,IP-TEMP,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
00883873761557 - LIFEPAK 35 Monitor/Defibrillator2024-09-12 LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
00883873761564 - LIFEPAK 35 Monitor/Defibrillator2024-09-12 LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR

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