CABLE,LOW LEVEL OUTPUT,GE

GUDID 10607567113784

Datascope Corp.

Electrical-only medical device connection cable, reusable
Primary Device ID10607567113784
NIH Device Record Key7f059ec7-c506-4793-afdf-1d382332d647
Commercial Distribution StatusIn Commercial Distribution
Brand NameCABLE,LOW LEVEL OUTPUT,GE
Version Model Number0012-00-1589-04
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110607567113784 [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 Date2024-08-05
Device Publish Date2024-07-26

Devices Manufactured by Datascope Corp.

10607567107301 - MEGA 8Fr. 50cc IAB2024-12-09 MEGA 8Fr. 50cc IAB
10607567107318 - MEGA 8Fr. 50cc IAB (with APA)2024-12-09 MEGA 8Fr. 50cc IAB (with APA)
10607567107479 - Arrow Pump Adapter - 5 Pack - for use with the Mega 8 Fr. 50cc IAB only2024-12-09 Arrow Pump Adapter - 5 Pack - for use with the Mega 8 Fr. 50cc IAB only
10607567107516 - Catheter Extenders for 50cc IAB’s 2024-12-09 Catheter Extenders for 50cc IAB’s
10607567108001 - MEGA 8Fr. 50cc IAB (with Statlock)2024-12-09 MEGA 8Fr. 50cc IAB (with Statlock)
10607567108018 - MEGA 8Fr. 50cc IAB (with Statlock & APA)2024-12-09 MEGA 8Fr. 50cc IAB (with Statlock & APA)
10607567108063 - SENSATION PLUS 7.5Fr. 40cc IAB & Accessories2024-12-09 SENSATION PLUS 7.5Fr. 40cc IAB & Accessories
10607567108605 - SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet)2024-12-09 SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet)

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.