LIFEPAK CR2 99512-001261

GUDID 00883873824139

CR2BAAAABFHBBBCDBCDBAAAA

PHYSIO-CONTROL, INC.

Non-rechargeable public semi-automated external defibrillator

• Primary Device ID: 00883873824139
• NIH Device Record Key: cfc8e789-3a09-425a-ab35-0384054a3ca8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIFEPAK CR2
• Version Model Number: 99512
• Catalog Number: 99512-001261
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *ALTHOUGH DESIGNED FOR A RANGE OF -30 TO 60 C (-22 TO 140 F), STORAGE AT THESE EXTREMES IS LIMITED TO ONE WEEK. STORAGE PAST THAT TIME WILL REDUCE THE ELECTRODE SHELF-LIFE AND BATTERY LIFE.
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *ALTHOUGH DESIGNED FOR A RANGE OF -30 TO 60 C (-22 TO 140 F), STORAGE AT THESE EXTREMES IS LIMITED TO ONE WEEK. STORAGE PAST THAT TIME WILL REDUCE THE ELECTRODE SHELF-LIFE AND BATTERY LIFE.
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *ALTHOUGH DESIGNED FOR A RANGE OF -30 TO 60 C (-22 TO 140 F), STORAGE AT THESE EXTREMES IS LIMITED TO ONE WEEK. STORAGE PAST THAT TIME WILL REDUCE THE ELECTRODE SHELF-LIFE AND BATTERY LIFE.
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883873824139 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P170018

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: 2019-02-08
• Device Publish Date: 2019-01-08

On-Brand Devices [LIFEPAK CR2]

• 00883873824139: CR2BAAAABFHBBBCDBCDBAAAA
• 00883873824122: CR2BBAAABFHBBBCDBCDBAAAA
• 00883873824115: CR2BAAAABBHBBBCDBCDBAAAA
• 00883873824108: CR2BBAAABBHBBBCDBCDBAAAA
• 00883873824092: CR2BAAAADHHBBBCDBCDBAAAA
• 00883873824085: CR2BBAAADHHBBBCDBCDBAAAA
• 00883873824078: CR2BAAAADDHBBBCDBCDBAAAA
• 00883873824061: CR2BBAAADDHBBBCDBCDBAAAA