PHILIPS HeartStart SMARTPADS II 989803139261

GUDID 00884838023703

HeartStart SMART Pads II

PHILIPS ELECTRONICS NORTH AMERICA CORPORATION

External defibrillator electrode, adult, single-use
Primary Device ID00884838023703
NIH Device Record Key834d8e50-5713-49ae-9415-52c796de3d0e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePHILIPS HeartStart SMARTPADS II
Version Model Number989803139261
Catalog Number989803139261
Company DUNS079503890
Company NamePHILIPS ELECTRONICS NORTH AMERICA CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838023703 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MKJAutomated External Defibrillators (Non-Wearable)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-24

Devices Manufactured by PHILIPS ELECTRONICS NORTH AMERICA CORPORATION

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00884838124196 - HeartStart2024-10-07 Primary Battery
00884838123922 - HeartStart2024-09-02 Primary Battery
00884838111325 - HeartStart Adult/Child Plus Pads2023-07-06 HeartStart Adult/Child Plus Pads
00884838055728 - HeartStart2023-04-14 CPR Compression Meter Adhesive Pads 10-Set
00884838111349 - HeartStart Adult/Child Plus Pads2022-08-04 HeartStart Infant Plus Pads
00884838111332 - Adult/Child Pre-Connect Defib Pad2022-08-04 Adult/Child Pre-Connect Defib Pad
00884838111493 - HeartStart2022-03-07 HS Adult/Child Radiolucent Pads

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