LIFE-PATCH® ECG Electrodes (4/pack) 11100-000002

GUDID 00681490587235

LIFEPATCH ECG ELECT ADULT 4 PER PAK

PHYSIO-CONTROL, INC.

Multifunction cardiac electrode, adult

• Primary Device ID: 00681490587235
• NIH Device Record Key: 64b77dd7-5881-419f-8155-737185d596d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIFE-PATCH® ECG Electrodes (4/pack)
• Version Model Number: 11100
• Catalog Number: 11100-000002
• 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	00681490587235 [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.

• 07613327666649 - LIFEPAK 15 MONITOR/DEFIBRILLATOR: 2025-02-17 USED LP15,EN,SPO2,3L,EX,CO2,TR,VR,BT,MNC,V4
• 07613327666656 - LIFEPAK 15 AC Power Adapter: 2025-02-17 ADAPTER, POWER, AC TO DC,ENHANCED, LP15
• 07613327666663 - LIFEPAK 15 MONITOR/DEFIBRILLATOR: 2025-02-17 USED LP15,EN,SPO2,3L,EX,CO2,TR,VR,MNC,V4
• 00883873933459 - LIFEPAK 15 Replacement Right Angle Cable for AC/DC Power Adapter: 2025-02-05 CABLE-EXTERNAL POWER, RIGHT ANGLE
• 00883873933466 - Extension Cable for AC/DC Power Adapter: 2025-02-05 CABLE-EXTERNAL POWER, EXTENSION
• 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