PHILIPS HeartStart Infant/Child SMART Pads

GUDID 00884838023758

HS1 Infant/Child SMART Pads Cartridge

PHILIPS ELECTRONICS NORTH AMERICA CORPORATION

External defibrillator electrode, paediatric, single-use

• Primary Device ID: 00884838023758
• NIH Device Record Key: 6d8e5830-3ee8-4b9c-b9e9-e5c972448616
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PHILIPS HeartStart Infant/Child SMART Pads
• Version Model Number: M5072A
• 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 10 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 110 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838023758 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020715

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

Devices Manufactured by PHILIPS ELECTRONICS NORTH AMERICA CORPORATION

• 00884838123939 - HeartStart: 2024-10-14 FRx Aviation Battery Pack
• 00884838124196 - HeartStart: 2024-10-07 Primary Battery
• 00884838123922 - HeartStart: 2024-09-02 Primary Battery
• 00884838111325 - HeartStart Adult/Child Plus Pads: 2023-07-06 HeartStart Adult/Child Plus Pads
• 00884838055728 - HeartStart: 2023-04-14 CPR Compression Meter Adhesive Pads 10-Set
• 00884838111349 - HeartStart Adult/Child Plus Pads: 2022-08-04 HeartStart Infant Plus Pads
• 00884838111332 - Adult/Child Pre-Connect Defib Pad: 2022-08-04 Adult/Child Pre-Connect Defib Pad
• 00884838111493 - HeartStart: 2022-03-07 HS Adult/Child Radiolucent Pads