11131-000045

GUDID 00883873863497

Sterilizable Internal Defibrillation Paddles, LP15

PHYSIO-CONTROL, INC.

Internal defibrillator electrode, paediatric

• Primary Device ID: 00883873863497
• NIH Device Record Key: 64dbf83a-4dcf-44a4-8c08-652c26b29a5f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 11131
• Catalog Number: 11131-000045
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@stryker.com

Device Dimensions

• Length: 6.3 Inch
• Device Size Text, specify: 0
• Length: 6.3 Inch
• Device Size Text, specify: 0
• Length: 6.3 Inch
• Device Size Text, specify: 0
• Length: 6.3 Inch
• Device Size Text, specify: 0
• Length: 6.3 Inch
• Device Size Text, specify: 0
• Length: 6.3 Inch
• Device Size Text, specify: 0
• Length: 6.3 Inch
• Device Size Text, specify: 0
• Length: 6.3 Inch
• Device Size Text, specify: 0
• Length: 6.3 Inch
• Device Size Text, specify: 0
• Length: 6.3 Inch
• Device Size Text, specify: 0
• Length: 6.3 Inch
• Device Size Text, specify: 0
• Length: 6.3 Inch
• Device Size Text, specify: 0
• Length: 6.3 Inch
• Device Size Text, specify: 0
• Length: 6.3 Inch
• Device Size Text, specify: 0
• Length: 6.3 Inch
• Device Size Text, specify: 0
• Length: 6.3 Inch
• Device Size Text, specify: 0
• Length: 6.3 Inch
• Device Size Text, specify: 0
• Length: 6.3 Inch
• Device Size Text, specify: 0
• Length: 6.3 Inch
• Device Size Text, specify: 0
• Length: 6.3 Inch
• Device Size Text, specify: 0
• Length: 6.3 Inch
• Device Size Text, specify: 0
• Length: 6.3 Inch
• Device Size Text, specify: 0
• Length: 6.3 Inch
• Device Size Text, specify: 0
• Length: 6.3 Inch
• Device Size Text, specify: 0
• Length: 6.3 Inch
• Device Size Text, specify: 0
• Length: 6.3 Inch
• Device Size Text, specify: 0
• Length: 6.3 Inch
• Device Size Text, specify: 0
• Length: 6.3 Inch
• Device Size Text, specify: 0
• Length: 6.3 Inch
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883873863497 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182503

FDA Product Code

• LDD: Dc-defibrillator, low-energy, (including paddles)

Sterilization

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

[00883873863497]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00883873863497]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00883873863497]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00883873863497]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00883873863497]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00883873863497]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00883873863497]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00883873863497]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00883873863497]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00883873863497]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00883873863497]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00883873863497]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00883873863497]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00883873863497]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00883873863497]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00883873863497]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00883873863497]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00883873863497]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00883873863497]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00883873863497]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00883873863497]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00883873863497]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00883873863497]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00883873863497]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00883873863497]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00883873863497]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00883873863497]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00883873863497]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00883873863497]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-14
• Device Publish Date: 2020-08-06

Devices Manufactured by PHYSIO-CONTROL, INC.

• 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
• 00883873761571 - LIFEPAK 35 Monitor/Defibrillator: 2024-09-12 LP35,EN-US,MAS-SP/CO,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
• 00883873761588 - LIFEPAK 35 Monitor/Defibrillator: 2024-09-12 LP35,EN-US,MAS-SP/CO,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
• 00883873761595 - LIFEPAK 35 Monitor/Defibrillator: 2024-09-12 LP35,EN-US,MAS-SP/CO/MET,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
• 00883873761601 - LIFEPAK 35 Monitor/Defibrillator: 2024-09-12 LP35,EN-US,MAS-SP/CO/MET,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR