LIFEPAK® 20 and LIFEPAK 20e defibrillator/monitors 97402-000005

GUDID 00885074856131

LP20 - CONFIGURED, AHA 2005, ENGLISH

PHYSIO-CONTROL, INC.

Physiologic-monitoring defibrillation system

• Primary Device ID: 00885074856131
• NIH Device Record Key: a5fd897a-98cf-4222-b307-182273e29dec
• Commercial Distribution Discontinuation: 2019-05-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: LIFEPAK® 20 and LIFEPAK 20e defibrillator/monitors
• Version Model Number: 97402
• Catalog Number: 97402-000005
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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@physio-control.com
• Phone: +1(800)442-1142
• Email: rs.seacustomersupport@physio-control.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

• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage at extreme temperatures of -20 to 60 C (-4 or 140 F) is limited to seven days. If storage at these temperatures exceeds one week, the electrode shelf-life is reduced.
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage at extreme temperatures of -20 to 60 C (-4 or 140 F) is limited to seven days. If storage at these temperatures exceeds one week, the electrode shelf-life is reduced.
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage at extreme temperatures of -20 to 60 C (-4 or 140 F) is limited to seven days. If storage at these temperatures exceeds one week, the electrode shelf-life is reduced.
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883873813898 [Primary]
GS1	00885074856131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160026

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: 3
• Public Version Date: 2019-05-09
• Device Publish Date: 2014-11-05

On-Brand Devices [LIFEPAK® 20 and LIFEPAK 20e defibrillator/monitors]

• 00885074856179: LP20 - CONFIGD,AHA 2005,PACING,SPO2,ENG
• 00885074856148: LP20 - CONFIGURED, AHA 2005, PACING, ENGLISH
• 00885074856131: LP20 - CONFIGURED, AHA 2005, ENGLISH
• 00885074854526: LP20E-CONFIGURED, AHA 2005, PACE, MNC SPO2, ENG
• 00885074852133: LP20E PACKAGE - CMM, PACING, SPO2, ENGLISH
• 00885074851921: LP20E PACKAGE - CMM,PCNG,MNC SPO2, ENGLISH
• 00885074851877: LP20E PACKAGE - CMM, PACING, ENGLISH
• 00885074851327: LP20E PACKAGE - CMM, ENGLISH
• 00885074790060: LP20 - CONFIGURED, AHA 2005, ENGLISH
• 00885074790053: LP20 - CONFIGURED, AHA 2005, PACING, ENGLISH
• 00885074789057: LP20 PACKAGE - AHA 2005,PACING, ENGLISH
• 00885074789040: LP20 PACKAGE - AHA 2005,PACING,SPO2,ENGLISH
• 00885074789033: LP20 - CONFIGD,AHA 2005,PACING,SPO2,ENG
• 00885074788999: LP20 PACKAGE - AHA 2005,ENGLISH
• 00885074515359: LP20E PACKAGE,PACING,ENGL,DOM
• 00885074515281: LP20E-CONFIGURED, AHA 2005,PCNG, SPO2,ENGLISH
• 00885074515267: LP20E - CONFIGURED, AHA2005 PACING, LI-ION, EN
• 00885074515250: LP20E - CONFIGURED,AHA 2005, LI-ION, ENGLISH
• 00885074512617: LP20 PACKAGE,PACING,SPO2 M, LI-ION,ENGL,DOM
• 00885074494371: LP20 PACKAGE,LI-ION,DOMENGL
• 00883873887806: LP20E CONFIGURED - CMM,ENGLISH
• 00883873887790: LP20E CONFIGURED - CMM,PACING, ENGLISH
• 00883873887707: LP20E CONFIGURED - CMM,PACING, SPO2,ENGLISH
• 00883873887660: LP20E CONFIGURED - CMM,PACING, MNC SPO2, ENG