11131-000022

GUDID 00883873806333

INTERN.PADDLE,CAMLK,2.0/5.1CM DIA, 8.75 L

PHYSIO-CONTROL, INC.

Internal defibrillator electrode, adult Internal defibrillation electrode, adult, reusable Internal defibrillation electrode, adult, reusable Internal defibrillation electrode, adult, reusable Internal defibrillation electrode, adult, reusable Internal defibrillation electrode, adult, reusable Internal defibrillation electrode, adult, reusable Internal defibrillation electrode, adult, reusable Internal defibrillation electrode, adult, reusable Internal defibrillation electrode, adult, reusable Internal defibrillation electrode, adult, reusable Internal defibrillation electrode, adult, reusable Internal defibrillation electrode, adult, reusable Internal defibrillation electrode, adult, reusable Internal defibrillation electrode, adult, reusable Internal defibrillation electrode, adult, reusable
Primary Device ID00883873806333
NIH Device Record Key7e14d242-861b-4261-96c2-6555379dd8a3
Commercial Distribution StatusIn Commercial Distribution
Version Model Number11131
Catalog Number11131-000022
Company DUNS009251992
Company NamePHYSIO-CONTROL, INC.
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 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@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 Identifiers

Device Issuing AgencyDevice ID
GS100883873806333 [Primary]

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00883873806333]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873806333]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873806333]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873806333]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873806333]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873806333]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873806333]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873806333]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873806333]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873806333]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873806333]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873806333]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873806333]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873806333]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873806333]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00883873806333]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-25
Device Publish Date2019-09-17

Devices Manufactured by PHYSIO-CONTROL, INC.

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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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