LIFEPAK® 20 and LIFEPAK 20e defibrillator/monitors 70507-000055

GUDID 00885074515359

LP20E PACKAGE,PACING,ENGL,DOM

PHYSIO-CONTROL, INC.

Physiologic-monitoring defibrillation system

• Primary Device ID: 00885074515359
• NIH Device Record Key: fd82e1d5-fc92-4c48-b4a8-2e7be8da1127
• 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: 70507
• Catalog Number: 70507-000055
• 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: 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@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
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• 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
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• 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
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883873813683 [Primary]
GS1	00885074515359 [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]

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