PHILIPS HeartStart HOME

GUDID 00884838049130

HeartStart Home Defibrillator, HS1

PHILIPS ELECTRONICS NORTH AMERICA CORPORATION

Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator Home automated external defibrillator

• Primary Device ID: 00884838049130
• NIH Device Record Key: 4e47bec4-7546-410a-8cbf-a047f2510a2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PHILIPS HeartStart HOME
• Version Model Number: M5068A
• 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	00884838049130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040904

FDA Product Code

• NSA: Over-The-Counter Automated External Defibrillator

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 HOME]

• 00884838076716: 861284
• 00884838049130: HeartStart Home Defibrillator, HS1