PHILIPS HeartStart SMARTPADS II 989803139261

GUDID 00884838023703

HeartStart SMART Pads II

PHILIPS ELECTRONICS NORTH AMERICA CORPORATION

External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use Multifunction cardiac electrode, adult Multifunction cardiac electrode, adult Multifunction cardiac electrode, adult Multifunction cardiac electrode, adult Multifunction cardiac electrode, adult

• Primary Device ID: 00884838023703
• NIH Device Record Key: 834d8e50-5713-49ae-9415-52c796de3d0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PHILIPS HeartStart SMARTPADS II
• Version Model Number: 989803139261
• Catalog Number: 989803139261
• 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 50 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838023703 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050004

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

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• 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
• 00884838106635 - HeartStart: 2021-11-08
• 00884838106642 - HeartStart: 2021-11-08
• 00884838106659 - HeartStart: 2021-11-08