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

• 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