Gel

GUDID 00847946021610

GEL DEFIBRILLATOR TUBE PD-5500, CE APPROVED

Zoll Medical Corporation

Rechargeable professional automated external defibrillator

Primary Device ID	00847946021610
NIH Device Record Key	68c72676-0105-448f-9c20-f33c2b03322b
Commercial Distribution Status	In Commercial Distribution
Brand Name	Gel
Version Model Number	0010-0004
Company DUNS	055363428
Company Name	Zoll Medical Corporation
Device Count	1
DM Exempt	true
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	false
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 Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847946021610 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K142915

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	2016-09-16

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