Adult/Child Pre-Connect Defib Pad 989803166021

GUDID 00884838111332

Adult/Child Pre-Connect Defib Pad

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 defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use
Primary Device ID00884838111332
NIH Device Record Key4b52abfa-d1a7-49a5-8749-d36efdfbe810
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdult/Child Pre-Connect Defib Pad
Version Model NumberHeartstart Pads
Catalog Number989803166021
Company DUNS079503890
Company NamePHILIPS ELECTRONICS NORTH AMERICA CORPORATION
Device Count10
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 Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838111332 [Unit of Use]
GS110884838022048 [Primary]

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 Number2
Public Version Date2022-08-04
Device Publish Date2022-01-06

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