CHARGE-PAK Charging Unit & 2 QUIK-PAK Electrodes 11403-000001

GUDID 00883873824603

SHIPPING ASSY-C-P, Q-P,REPL KIT, 2 ELECTRODE

PHYSIO-CONTROL, INC.

External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use
Primary Device ID00883873824603
NIH Device Record Keyefb87930-fd56-4262-9a29-7fdb16b959c3
Commercial Distribution StatusIn Commercial Distribution
Brand NameCHARGE-PAK Charging Unit & 2 QUIK-PAK Electrodes
Version Model Number11403
Catalog Number11403-000001
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100883873824603 [Primary]

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 Date2023-02-28
Device Publish Date2023-02-20

Devices Manufactured by PHYSIO-CONTROL, INC.

50883873784933 - EDGE SYSTEM2023-07-06 EDGE System RTS (Radiotransparent) Electrodes with QUIK-COMBO Connector
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 Electrodes2023-02-28SHIPPING ASSY-C-P, Q-P,REPL KIT, 2 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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