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

GUDID 00681490587228

LIFEPATCH ECG ELECT,ADULT 3/PER PAK

PHYSIO-CONTROL, INC.

Multifunction cardiac electrode, adult 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.

• 50883873784933 - EDGE SYSTEM: 2023-07-06 EDGE System RTS (Radiotransparent) Electrodes with QUIK-COMBO Connector
• 50883873784940 - EDGE SYSTEM: 2023-07-06 EDGE System Electrodes with QUIK-COMBO Connector
• 50883873784964 - EDGE SYSTEM: 2023-07-06 EDGE System Electrodes with QUIK-COMBO Connector and REDI-PAK Preconnect System
• 00883873772676 - Emergency Response Kit: 2023-03-20 Emergency Response Kit
• 00883873824597 - Replacement Kit for CHARGE-PAK battery charger: 2023-02-28 SHIPPING ASSY-C-P, Q-P,REPL KIT, 1 ELECTRODE
• 00883873824603 - CHARGE-PAK Charging Unit & 2 QUIK-PAK Electrodes: 2023-02-28 SHIPPING ASSY-C-P, Q-P,REPL KIT, 2 ELECTRODE
• 00883873824610 - ELECTRODE ASSY-QUIK-COMBO: 2023-02-28 ELECTRODE ASSY-QUIK-COMBO QUIK-PAK,SET,WW
• 00883873793497 - NA: 2020-12-10 LP1000 ASSEMBLY BATTERY REPLACEMENT KIT