1/4" ECC Pack with RF32 701055142

GUDID 00607567203730

Softshell Venous Reser. 800ml, Blood Transfer Bag 1000 ml - 2 spike ports, BEQ-RF32 RotaFlow, Blood Microfilter System SQ 40 S, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set

• Primary Device ID: 00607567203730
• NIH Device Record Key: f86b4f19-f061-40e7-af6d-566cc8a59dcc
• Commercial Distribution Discontinuation: 2018-12-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: 1/4" ECC Pack with RF32
• Version Model Number: BEQ-T 8025
• Catalog Number: 701055142
• 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: false
• Labeled No Natural Rubber Latex: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607567203730 [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

[00607567203730]

Ethylene Oxide

[00607567203730]

Ethylene Oxide

[00607567203730]

Ethylene Oxide

[00607567203730]

Ethylene Oxide

[00607567203730]

Ethylene Oxide

[00607567203730]

Ethylene Oxide

[00607567203730]

Ethylene Oxide

[00607567203730]

Ethylene Oxide

[00607567203730]

Ethylene Oxide

[00607567203730]

Ethylene Oxide

[00607567203730]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-12-02
• Device Publish Date: 2017-03-28

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)