CPRmeter 801-00149

GUDID 07045432055290

The CPRmeter™ CPR feedback device is used as a guide in administering CPR to a suspected sudden cardiac arrest (SCA) victim. The feedback is provided

Laerdal Medical AS

Cardiopulmonary resuscitation feedback device, electronic

• Primary Device ID: 07045432055290
• NIH Device Record Key: 47b4fe44-cb97-45b2-8d6f-6cfb68d5ce7d
• Commercial Distribution Discontinuation: 2016-11-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CPRmeter
• Version Model Number: 801
• Catalog Number: 801-00149
• Company DUNS: 730624095
• Company Name: Laerdal Medical AS
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800) 431-1055
• Email: customerservice@laerdal.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07045432055290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122050

FDA Product Code

• LIX: Aid, Cardiopulmonary Resuscitation

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: 2018-07-06
• Device Publish Date: 2014-10-22

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