EDGE Electrodes with REDI-PAK™ Preconnect System 11996-000017

GUDID 00681490580656

ELECT ASSY-EDGE,QUIK-COMBO REDI-PAK,WW

PHYSIO-CONTROL, INC.

External defibrillator electrode, adult, single-use
Primary Device ID00681490580656
NIH Device Record Key1dd95b69-a216-41d9-a139-2faf552f5000
Commercial Distribution StatusIn Commercial Distribution
Brand NameEDGE Electrodes with REDI-PAK™ Preconnect System
Version Model Number11996
Catalog Number11996-000017
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100681490580656 [Primary]
GS120681490580650 [Package]
Package: Shelf Pak [10 Units]
In Commercial Distribution
GS140681490580654 [Package]
Contains: 20681490580650
Package: Case [50 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 Date2014-11-10

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00883873777466 - LIFEPAK 15 MONITOR/DEFIBRILLATOR2024-11-18 15AABAAABABBBABAAAAAAABFLP15 MONITOR/DEFIB
00883873907252 - NA2024-10-28 CABLE-ADAPTER,LP15 INTERNAL PADDLES,ROHS,3RD EDT
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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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