CARDIOSAVE HYBRID - TYPE "N" PLUG 0998-00-0800-36

GUDID 10607567114187

CARDIOSAVE HYBRID - TYPE "N" PLUG

Datascope Corp.

Intra-aortic balloon pump
Primary Device ID10607567114187
NIH Device Record Keyc79a1c66-4b7f-4d7d-ab51-eb0fe0376c68
Commercial Distribution StatusIn Commercial Distribution
Brand NameCARDIOSAVE HYBRID - TYPE "N" PLUG
Version Model Number0998-00-0800-36
Catalog Number0998-00-0800-36
Company DUNS040874329
Company NameDatascope Corp.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 483 Millimeter of Mercury and 795 Millimeter of Mercury
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110607567114187 [Primary]

FDA Product Code

DSPSystem, Balloon, Intra-Aortic And Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-17
Device Publish Date2024-09-09

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10607567114187 - CARDIOSAVE HYBRID - TYPE "N" PLUG2024-09-17CARDIOSAVE HYBRID - TYPE "N" PLUG
10607567114187 - CARDIOSAVE HYBRID - TYPE "N" PLUG2024-09-17 CARDIOSAVE HYBRID - TYPE "N" PLUG
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10607567107592 - YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA)2024-08-20 YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA)
10607567107608 - YAMATO PLUS-R 35cc IAB WITH ACCESSORIES AND RETRACTION KIT2024-08-20 YAMATO PLUS-R 35cc IAB WITH ACCESSORIES AND RETRACTION KIT
10607567107639 - YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA)2024-08-20 YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA)
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