11103-000037

GUDID 00883873790687

ELECTRODES, 5-YEAR, LPCR2, LL

PHYSIO-CONTROL, INC.

Multifunction cardiac electrode, adult

• Primary Device ID: 00883873790687
• NIH Device Record Key: 33245393-fc21-411a-b3c6-aaa7d431289e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 11103
• Catalog Number: 11103-000037
• Company DUNS: 009251992
• Company Name: PHYSIO-CONTROL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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: false
• OTC Over-The-Counter: true

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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883873790687 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P170018

FDA Product Code

• DRX: Electrode, electrocardiograph

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: 2019-05-28
• Device Publish Date: 2019-05-20

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