EDGE SYSTEM 11996-000091

GUDID 50883873784940

EDGE System Electrodes with QUIK-COMBO Connector

PHYSIO-CONTROL, INC.

External defibrillation electrode, adult, single-use

• Primary Device ID: 50883873784940
• NIH Device Record Key: 271a27b0-0213-4830-b016-b5f08f344aa2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EDGE SYSTEM
• Version Model Number: 11996
• Catalog Number: 11996-000091
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00721902195075 [Previous]
GS1	00883873784945 [Primary]
GS1	30883873784946 [Package]; Contains: 00883873784945; Package: pack [10 Units]; In Commercial Distribution
GS1	50883873784940 [Package]; Contains: 30883873784946; Package: case [50 Units]; In Commercial Distribution

FDA Product Code

• MKJ: Automated external defibrillators (non-wearable)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-07-06
• Device Publish Date: 2020-11-03

On-Brand Devices [EDGE SYSTEM]

• 50883873784957: Pediatric EDGE System RTS (Radiotransparent) Electrodes with QUIK-COMBO Connector
• 50883873784964: EDGE System Electrodes with QUIK-COMBO Connector and REDI-PAK Preconnect System
• 50883873784940: EDGE System Electrodes with QUIK-COMBO Connector
• 50883873784933: EDGE System RTS (Radiotransparent) Electrodes with QUIK-COMBO Connector