Open Heart Pack no PLEGIOX 701067364R02

GUDID 00607567210479

BEQ-HMO 71000 Quadrox i Adult with integral filter, BO-VHK 71000 Venous Reservoir, Blood Transfer Bag 1000 ml - 2 spike ports, BEQ-RF32 RotaFlow, BC 60 plus, CDI Sat Cell 1/2" System 100, CDI Sat Cell 1/4" System 100, Prebypass filter w/o Vent Porous Media 3/8x1/2, Gas Filter.

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 00607567210479
• NIH Device Record Key: 4b08eafd-bba0-49a2-b183-c5b9a7b8a90a
• Commercial Distribution Discontinuation: 2018-07-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Open Heart Pack no PLEGIOX
• Version Model Number: BEQ-TOP 40010
• Catalog Number: 701067364R02
• 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	00607567210479 [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

[00607567210479]

Ethylene Oxide

[00607567210479]

Ethylene Oxide

[00607567210479]

Ethylene Oxide

[00607567210479]

Ethylene Oxide

[00607567210479]

Ethylene Oxide

[00607567210479]

Ethylene Oxide

[00607567210479]

Ethylene Oxide

[00607567210479]

Ethylene Oxide

[00607567210479]

Ethylene Oxide

[00607567210479]

Ethylene Oxide

[00607567210479]

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: 2016-10-04

On-Brand Devices [Open Heart Pack no PLEGIOX]

• 00607567210479: BEQ-HMO 71000 Quadrox i Adult with integral filter, BO-VHK 71000 Venous Reservoir, Blood Transfe
• 00607567206304: BEQ-HMOD 71000 BO-VHK 71000 Blood Transfer Bag 1000 BEQ- RF Rotaflow BC 60plus cdi SAT 1/2" preb