11131-000047

GUDID 00883873863213

Sterilizable Internal Defibrillation Paddles, LP15

PHYSIO-CONTROL, INC.

Internal defibrillator electrode, paediatric Internal defibrillator electrode, paediatric Internal defibrillator electrode, paediatric Internal defibrillator electrode, paediatric Internal defibrillator electrode, paediatric Internal defibrillator electrode, paediatric Internal defibrillator electrode, paediatric Internal defibrillator electrode, paediatric Internal defibrillator electrode, paediatric Internal defibrillator electrode, paediatric Internal defibrillator electrode, paediatric Internal defibrillator electrode, paediatric Internal defibrillator electrode, paediatric Internal defibrillator electrode, paediatric Internal defibrillation electrode, paediatric Internal defibrillation electrode, paediatric Internal defibrillation electrode, paediatric Internal defibrillation electrode, paediatric Internal defibrillation electrode, paediatric Internal defibrillation electrode, paediatric Internal defibrillation electrode, paediatric Internal defibrillation electrode, paediatric Internal defibrillation electrode, paediatric Internal defibrillation electrode, paediatric Internal defibrillation electrode, paediatric Internal defibrillation electrode, paediatric Internal defibrillation electrode, paediatric Internal defibrillation electrode, paediatric Internal defibrillation electrode, paediatric
Primary Device ID00883873863213
NIH Device Record Key5defd429-a92b-4663-bec8-4660380dd0e9
Commercial Distribution StatusIn Commercial Distribution
Version Model Number11131
Catalog Number11131-000047
Company DUNS009251992
Company NamePHYSIO-CONTROL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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 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@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@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@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@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@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@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@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@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@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com

Device Dimensions

Length5.9 Inch
Device Size Text, specify0
Length5.9 Inch
Device Size Text, specify0
Length5.9 Inch
Device Size Text, specify0
Length5.9 Inch
Device Size Text, specify0
Length5.9 Inch
Device Size Text, specify0
Length5.9 Inch
Device Size Text, specify0
Length5.9 Inch
Device Size Text, specify0
Length5.9 Inch
Device Size Text, specify0
Length5.9 Inch
Device Size Text, specify0
Length5.9 Inch
Device Size Text, specify0
Length5.9 Inch
Device Size Text, specify0
Length5.9 Inch
Device Size Text, specify0
Length5.9 Inch
Device Size Text, specify0
Length5.9 Inch
Device Size Text, specify0
Length5.9 Inch
Device Size Text, specify0
Length5.9 Inch
Device Size Text, specify0
Length5.9 Inch
Device Size Text, specify0
Length5.9 Inch
Device Size Text, specify0
Length5.9 Inch
Device Size Text, specify0
Length5.9 Inch
Device Size Text, specify0
Length5.9 Inch
Device Size Text, specify0
Length5.9 Inch
Device Size Text, specify0
Length5.9 Inch
Device Size Text, specify0
Length5.9 Inch
Device Size Text, specify0
Length5.9 Inch
Device Size Text, specify0
Length5.9 Inch
Device Size Text, specify0
Length5.9 Inch
Device Size Text, specify0
Length5.9 Inch
Device Size Text, specify0
Length5.9 Inch
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100883873863213 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LDDDc-defibrillator, low-energy, (including paddles)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00883873863213]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873863213]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873863213]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873863213]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873863213]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873863213]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873863213]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873863213]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873863213]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873863213]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873863213]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873863213]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873863213]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873863213]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873863213]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873863213]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873863213]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873863213]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873863213]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873863213]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873863213]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873863213]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873863213]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873863213]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873863213]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873863213]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873863213]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873863213]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873863213]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-14
Device Publish Date2020-08-06

Devices Manufactured by PHYSIO-CONTROL, INC.

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50883873784940 - EDGE SYSTEM2023-07-06 EDGE System Electrodes with QUIK-COMBO Connector
50883873784964 - EDGE SYSTEM2023-07-06 EDGE System Electrodes with QUIK-COMBO Connector and REDI-PAK Preconnect System
00883873772676 - Emergency Response Kit2023-03-20 Emergency Response Kit
00883873824597 - Replacement Kit for CHARGE-PAK battery charger2023-02-28 SHIPPING ASSY-C-P, Q-P,REPL KIT, 1 ELECTRODE
00883873824603 - CHARGE-PAK Charging Unit & 2 QUIK-PAK Electrodes2023-02-28 SHIPPING ASSY-C-P, Q-P,REPL KIT, 2 ELECTRODE
00883873824610 - ELECTRODE ASSY-QUIK-COMBO2023-02-28 ELECTRODE ASSY-QUIK-COMBO QUIK-PAK,SET,WW
00883873793497 - NA2020-12-10 LP1000 ASSEMBLY BATTERY REPLACEMENT KIT

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