LIFEPAK® 1000 defibrillator 99425-000014

GUDID 00885074630564

LP1000 CONFIGURED UNIT1000AAAABAAAABAAAAAAAAAA

PHYSIO-CONTROL, INC.

Non-rechargeable professional semi-automated external defibrillator

• Primary Device ID: 00885074630564
• NIH Device Record Key: 7a4787af-0b5a-4027-9650-61050ed7635d
• Commercial Distribution Discontinuation: 2019-05-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: LIFEPAK® 1000 defibrillator
• Version Model Number: 99425
• Catalog Number: 99425-000014
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Storage at extreme temperatures of -30C to 50C (-22F to 140F) is limited to 7 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
• Special Storage Condition, Specify: Between 0 and 0 *Storage at extreme temperatures of -30C to 60C (-22F to 140F) is limited to 7 days. If storage at these temperatures exceeds one week, the electrode shelf-life is reduced.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• 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
• Special Storage Condition, Specify: Between 0 and 0 *Storage at extreme temperatures of -30C to 60C (-22F to 140F) is limited to 7 days. If storage at these temperatures exceeds one week, the electrode shelf-life is reduced.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• 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
• Special Storage Condition, Specify: Between 0 and 0 *Storage at extreme temperatures of -30C to 60C (-22F to 140F) is limited to 7 days. If storage at these temperatures exceeds one week, the electrode shelf-life is reduced.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883873815441 [Primary]
GS1	00885074630564 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160026
• 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: 2014-11-24

On-Brand Devices [LIFEPAK® 1000 defibrillator]

• 00885074698953: LP1000 CONFIGURED UNIT1000AAAABAAACBAAAAAAAAAA
• 00885074698878: LP1000 CONFIGURED UNIT1000AAAAAAAACAAAAAAAAAAA
• 00885074630564: LP1000 CONFIGURED UNIT1000AAAABAAAABAAAAAAAAAA
• 00885074630472: LP1000 CONFIGURED UNIT1000AAAAAAAAAAAAAAAAAAAA
• 00885074514666: LP1000 CONFIGURED UNIT1000AAAAAAAAAAAAAAAAAAAA
• 00883873869581: USED LP1000 CONFIG UNIT1000AAAAAAAACAAAAAAAAAAA
• 00883873869574: USED LP1000 UNIT1000AAAABAAACBAAAAAAAAAA
• 00883873869567: USED LP1000 UNIT1000AAAAAAAACAAAAAAAAAAA
• 00883873869550: USED LP1000 UNIT1000AAAABAAACBAAAAAAAAAA