PHILIPS FR/FR2/FR2+ Adult Electrode Pads 989803158221

GUDID 00884838029569

5-pack HS FR/FR2 Defib Pads (DP2/DP6)

PHILIPS ELECTRONICS NORTH AMERICA CORPORATION

External defibrillator electrode, adult, single-use

• Primary Device ID: 00884838029569
• NIH Device Record Key: 4e326e91-e7b7-41c2-a4c7-54c62ddf878a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PHILIPS FR/FR2/FR2+ Adult Electrode Pads
• Version Model Number: 989803158221
• Catalog Number: 989803158221
• Company DUNS: 079503890
• Company Name: PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
• Device Count: 5
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00884838029552 [Unit of Use]
GS1	00884838029569 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955628

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 FR/FR2/FR2+ Adult Electrode Pads]

• 00884838029569: 5-pack HS FR/FR2 Defib Pads (DP2/DP6)
• 00884838023710: 1-pack HS FR/FR2 Defib Pads (DP2/DP6)
• 00884838023727: 989803158221