LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors 97402-000003

GUDID 00721902665301

LP20-CONFIGURED,W/PACING,SPO2,ENGLISH

PHYSIO-CONTROL, INC.

Physiologic-monitoring defibrillation system

• Primary Device ID: 00721902665301
• NIH Device Record Key: f9e42a96-9128-46f2-8972-167db3fb5b83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors
• Version Model Number: 97402
• Catalog Number: 97402-000003
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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@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

• Special Storage Condition, Specify: Between 0 and 0 *Storage at extreme temperatures of -20¿ to 60¿ celsius (-4¿ or 140¿ Fahrenheit) is limited to seven days. If storage at these temperatures exceeds one week, the electrode shelf-life is reduced.
• 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 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 celsius (-4 or 140 Fahrenheit) is limited to seven days. If storage at these temperatures exceeds one week, the electrode shelf-life is reduced.
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• 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 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 celsius (-4 or 140 Fahrenheit) is limited to seven days. If storage at these temperatures exceeds one week, the electrode shelf-life is reduced.
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• 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 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 celsius (-4 or 140 Fahrenheit) is limited to seven days. If storage at these temperatures exceeds one week, the electrode shelf-life is reduced.
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00721902665301 [Primary]
GS1	00883873813911 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-24
• Device Publish Date: 2019-04-16

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

• 00721902665301: LP20-CONFIGURED,W/PACING,SPO2,ENGLISH
• 00721902665233: LP20-CONFIGURED,WITH PACING,ENGLISH
• 00721902665103: LP20-CONFIGURED,W/O PACING,ENGLISH
• 00721902505461: LP20-CONFIGURED,W/PACING,SPO2,ENGLISH
• 00721902505140: LP20-CONFIGURED,WITH PACING,ENGLISH
• 00721902504426: LP20-CONFIGURED,W/O PACING,ENGLISH
• 00721902439681: LP20 PACKAGE,PACING,SPO2M,ENGL,DOM
• 00721902439339: LP20 PACKAGE,PACING,ENGL,DOM
• 00721902438653: LP20 PACKAGE,W/OUT PACING,ENGL,DOM
• 00883873853962: Pkg LP20e CMM,AHA USAS,ENG
• 00883873853863: Pkg LP20e CMM,PCNG,AHA USAS,ENG
• 00883873852804: Pkg LP20e CMM,PCNG,SpO2,AHA USAS,ENG
• 00883873852798: Pkg LP20e CMM,PCNG,MNC,SpO2,AHA USAS,ENG