HeartStart MRx monitor/defib 860397

GUDID 00884838045910

Philips Medical Systems

Rechargeable professional automated external defibrillator

• Primary Device ID: 00884838045910
• NIH Device Record Key: a99a0fb3-3ccc-4670-8b54-a9c1a8105e78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HeartStart MRx monitor/defib
• Version Model Number: 860397
• Catalog Number: 860397
• Company DUNS: 078628040
• Company Name: Philips Medical Systems
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(999)999-9999
• Email: xx@xx.xx
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838045910 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031187

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: 2018-07-06
• Device Publish Date: 2016-08-10

On-Brand Devices [HeartStart MRx monitor/defib]

• 00884838045927: 860398
• 00884838045910: 860397
• 00884838045903: 860396
• 00884838027961: 861491
• 00884838023659: 861482
• 00884838006683: 861465
• 00884838006676: 861464