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

• Primary Device ID: 00883873824603
• NIH Device Record Key: efb87930-fd56-4262-9a29-7fdb16b959c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHARGE-PAK Charging Unit & 2 QUIK-PAK Electrodes
• Version Model Number: 11403
• Catalog Number: 11403-000001
• Company DUNS: 009251992
• Company Name: PHYSIO-CONTROL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883873824603 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160012

FDA Product Code

• MKJ: Automated external defibrillators (non-wearable)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-28
• Device Publish Date: 2023-02-20

Devices Manufactured by PHYSIO-CONTROL, INC.

• 00883873761434 - STANDARD HARD PADDLES: 2024-11-18 PADDLE ASSY - HARD PADDLE, ENGLISH,ROHS,LP15
• 00883873761441 - PEDIATRIC PADDLE, EXTERNAL: 2024-11-18 ASSY PEDIATRIC PADDLE,MULTI LANGUAGE, 3RD EDT
• 00883873777466 - LIFEPAK 15 MONITOR/DEFIBRILLATOR: 2024-11-18 15AABAAABABBBABAAAAAAABFLP15 MONITOR/DEFIB
• 00883873907252 - NA: 2024-10-28 CABLE-ADAPTER,LP15 INTERNAL PADDLES,ROHS,3RD EDT
• 00883873761533 - LIFEPAK 35 Monitor/Defibrillator: 2024-09-12 LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,IP-TEMP,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
• 00883873761540 - LIFEPAK 35 Monitor/Defibrillator: 2024-09-12 LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,IP-TEMP,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
• 00883873761557 - LIFEPAK 35 Monitor/Defibrillator: 2024-09-12 LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
• 00883873761564 - LIFEPAK 35 Monitor/Defibrillator: 2024-09-12 LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR