PHILIPS FR2/FR2+ Infant/Child Defibrillation Pads

GUDID 00884838023734

FR2 AED Pediatric Defibrillation Pads

PHILIPS ELECTRONICS NORTH AMERICA CORPORATION

External defibrillator electrode, paediatric, single-use

• Primary Device ID: 00884838023734
• NIH Device Record Key: b084e666-9862-4ec6-ac34-3b717891fc9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PHILIPS FR2/FR2+ Infant/Child Defibrillation Pads
• Version Model Number: M3870A
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838023734 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003819

FDA Product Code

• MLN: Electrode, Electrodcardiograph, Multi-Function

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

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