LIFE-PATCH® ECG Electrodes (3/pack) 11100-000001

GUDID 00681490587228

LIFEPATCH ECG ELECT,ADULT 3/PER PAK

PHYSIO-CONTROL, INC.

Multifunction cardiac electrode, adult

• Primary Device ID: 00681490587228
• NIH Device Record Key: a33fc4a3-c677-46a3-b458-4d9311b71656
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIFE-PATCH® ECG Electrodes (3/pack)
• Version Model Number: 11100
• Catalog Number: 11100-000001
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00681490587228 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091856

FDA Product Code

• DRX: Electrode, electrocardiograph

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

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