Model Eagle II, MRI

GUDID 00847946023454

Zoll Medical Corporation

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Primary Device ID	00847946023454
NIH Device Record Key	ee4d2e43-ba32-4899-ae4e-5fdb0b450b80
Commercial Distribution Status	In Commercial Distribution
Brand Name	Model Eagle II, MRI
Version Model Number	799-EGL2-02-01
Company DUNS	055363428
Company Name	Zoll Medical Corporation
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Safe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
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 Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
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	00847946023454 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K111473

FDA Product Code

DQA

Oximeter

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-10-30
Device Publish Date	2020-10-22

On-Brand Devices [Model Eagle II, MRI]

00847946020910	799-EGL2-02
00847946020699	Ventilator
00847946023454	799-EGL2-02-01