PHILIPS HeartStart FR2+ with ECG 861364

GUDID 00884838050723

Guideline 2005 Exch, FR2+ ECG, Philips

PHILIPS ELECTRONICS NORTH AMERICA CORPORATION

Non-rechargeable public automated external defibrillator

• Primary Device ID: 00884838050723
• NIH Device Record Key: cf42b045-825a-4ade-bf88-90e95e474b13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PHILIPS HeartStart FR2+ with ECG
• Version Model Number: 861364
• Catalog Number: 861364
• Company DUNS: 079503890
• Company Name: PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838050723 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051632

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: 2014-09-24

On-Brand Devices [PHILIPS HeartStart FR2+ with ECG]

• 00884838050723: Guideline 2005 Exch, FR2+ ECG, Philips
• 00884838050389: HS Refurbished FR2+ AED, with ECG