CS300 Intra-Aortic Balloon Pump, Refurbished, SPANISH,NON-UTS,INT'L 0998-UC-3023-58

GUDID 10607567108759

CS300 Intra-Aortic Balloon Pump, Refurbished, SPANISH,NON-UTS,INT'L

Datascope Corp.

Intra-aortic balloon pump Intra-aortic balloon pump Intra-aortic balloon pump Intra-aortic balloon pump Intra-aortic balloon pump Intra-aortic balloon pump Intra-aortic balloon pump Intra-aortic balloon pump Intra-aortic balloon pump Intra-aortic balloon pump Intra-aortic balloon pump Intra-aortic balloon pump Intra-aortic balloon pump Intra-aortic balloon pump Intra-aortic balloon pump

Primary Device ID	10607567108759
NIH Device Record Key	c1d47913-addc-47b4-9ccd-437a1c55bbef
Commercial Distribution Status	In Commercial Distribution
Brand Name	CS300 Intra-Aortic Balloon Pump, Refurbished, SPANISH,NON-UTS,INT'L
Version Model Number	0998-UC-3023-58
Catalog Number	0998-UC-3023-58
Company DUNS	040874329
Company Name	Datascope Corp.
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	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	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	888-627-8383
Email	customer.support@maquet.com
Phone	888-627-8383
Email	customer.support@maquet.com
Phone	888-627-8383
Email	customer.support@maquet.com
Phone	888-627-8383
Email	customer.support@maquet.com
Phone	888-627-8383
Email	customer.support@maquet.com
Phone	888-627-8383
Email	customer.support@maquet.com
Phone	888-627-8383
Email	customer.support@maquet.com
Phone	888-627-8383
Email	customer.support@maquet.com
Phone	888-627-8383
Email	customer.support@maquet.com
Phone	888-627-8383
Email	customer.support@maquet.com
Phone	888-627-8383
Email	customer.support@maquet.com
Phone	888-627-8383
Email	customer.support@maquet.com
Phone	888-627-8383
Email	customer.support@maquet.com
Phone	888-627-8383
Email	customer.support@maquet.com
Phone	888-627-8383
Email	customer.support@maquet.com

Operating and Storage Conditions

Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 483 Millimeter of Mercury and 795 Millimeter of Mercury
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 Atmospheric Pressure	Between 483 Millimeter of Mercury and 795 Millimeter of Mercury
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 Atmospheric Pressure	Between 483 Millimeter of Mercury and 795 Millimeter of Mercury
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 Atmospheric Pressure	Between 483 Millimeter of Mercury and 795 Millimeter of Mercury
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 Atmospheric Pressure	Between 483 Millimeter of Mercury and 795 Millimeter of Mercury
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 Atmospheric Pressure	Between 483 Millimeter of Mercury and 795 Millimeter of Mercury
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 Atmospheric Pressure	Between 483 Millimeter of Mercury and 795 Millimeter of Mercury
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 Atmospheric Pressure	Between 483 Millimeter of Mercury and 795 Millimeter of Mercury
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 Atmospheric Pressure	Between 483 Millimeter of Mercury and 795 Millimeter of Mercury
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 Atmospheric Pressure	Between 483 Millimeter of Mercury and 795 Millimeter of Mercury
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 Atmospheric Pressure	Between 483 Millimeter of Mercury and 795 Millimeter of Mercury
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 Atmospheric Pressure	Between 483 Millimeter of Mercury and 795 Millimeter of Mercury
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 Atmospheric Pressure	Between 483 Millimeter of Mercury and 795 Millimeter of Mercury
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 Atmospheric Pressure	Between 483 Millimeter of Mercury and 795 Millimeter of Mercury
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10607567108759 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K063525

FDA Product Code

DSP	System, Balloon, Intra-Aortic And Control

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2020-05-06
Device Publish Date	2016-09-23