Sm Patient ECC Pack QPiD 701050839

GUDID 00607567201606

BEQ-HMOD 30000 Blood Transfer Bag 1000mL Better Bladder 1/4 BEQ RF 32 CDI Sat Cell 1/4" Prebypass Filter with out vent porous media 3/8 by 3/8 Pediatric Temp Probe

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set

• Primary Device ID: 00607567201606
• NIH Device Record Key: 0bff2244-97c7-4aaf-b056-dd53616d3af2
• Commercial Distribution Discontinuation: 2019-10-26
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Sm Patient ECC Pack QPiD
• Version Model Number: BEQ-TOP 4901
• Catalog Number: 701050839
• Company DUNS: 001660786
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18886278383
• Email: cpsurgery@maquet.com
• Phone: 18886278383
• Email: cpsurgery@maquet.com
• Phone: 18886278383
• Email: cpsurgery@maquet.com
• Phone: 18886278383
• Email: cpsurgery@maquet.com
• Phone: 18886278383
• Email: cpsurgery@maquet.com
• Phone: 18886278383
• Email: cpsurgery@maquet.com
• Phone: 18886278383
• Email: cpsurgery@maquet.com
• Phone: 18886278383
• Email: cpsurgery@maquet.com
• Phone: 18886278383
• Email: cpsurgery@maquet.com
• Phone: 18886278383
• Email: cpsurgery@maquet.com
• Phone: 18886278383
• Email: cpsurgery@maquet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607567201606 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080592

FDA Product Code

• DWE: Tubing, Pump, Cardiopulmonary Bypass

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00607567201606]

Ethylene Oxide

[00607567201606]

Ethylene Oxide

[00607567201606]

Ethylene Oxide

[00607567201606]

Ethylene Oxide

[00607567201606]

Ethylene Oxide

[00607567201606]

Ethylene Oxide

[00607567201606]

Ethylene Oxide

[00607567201606]

Ethylene Oxide

[00607567201606]

Ethylene Oxide

[00607567201606]

Ethylene Oxide

[00607567201606]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-28
• Device Publish Date: 2016-02-14

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)