M1742A

GUDID 00884838002098

Large Switchless Internal Paddle

Philips Medical Systems

Internal defibrillator electrode, adult

Primary Device ID	00884838002098
NIH Device Record Key	c47111e8-db49-4d6f-9fed-2982541d0e04
Commercial Distribution Status	In Commercial Distribution
Version Model Number	989803105051
Catalog Number	M1742A
Company DUNS	078628040
Company Name	Philips Medical Systems
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	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
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 -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838002098 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K021453

FDA Product Code

LDD	Dc-Defibrillator, Low-Energy, (Including Paddles)
MKJ	Automated External Defibrillators (Non-Wearable)