CARDIOSAVE LI-ION SINGLE BTTY TRANSPORT

GUDID 10607567112817

Datascope Corp.

Battery box

• Primary Device ID: 10607567112817
• NIH Device Record Key: d85733f9-3794-44f1-89b7-86a341edaa1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARDIOSAVE LI-ION SINGLE BTTY TRANSPORT
• Version Model Number: 0202-00-0206-01
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10607567112817 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-05
• Device Publish Date: 2024-07-26

Devices Manufactured by Datascope Corp.

• 10607567107301 - MEGA 8Fr. 50cc IAB: 2024-12-09 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 only: 2024-12-09 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 & Accessories: 2024-12-09 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)