Open Heart Pack 701052489R01

GUDID 00607567208650

BEQ-HMO 71000 Quadrox i Adult with integral filter VHK 71000 Venous Reservoir - uncoated BEQ-RF32 RotaFlow BMU Cell Ven. 1/2 Prebypass filter w/o Vent 1/2 - 1/2 Bacteria filter Gas Filter

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set

• Primary Device ID: 00607567208650
• NIH Device Record Key: a8c9f155-8055-41e4-aba3-d0fe065b1841
• Commercial Distribution Discontinuation: 2017-04-12
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Open Heart Pack
• Version Model Number: BEQ-TOP 29400
• Catalog Number: 701052489R01
• 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	00607567208650 [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

[00607567208650]

Ethylene Oxide

[00607567208650]

Ethylene Oxide

[00607567208650]

Ethylene Oxide

[00607567208650]

Ethylene Oxide

[00607567208650]

Ethylene Oxide

[00607567208650]

Ethylene Oxide

[00607567208650]

Ethylene Oxide

[00607567208650]

Ethylene Oxide

[00607567208650]

Ethylene Oxide

[00607567208650]

Ethylene Oxide

[00607567208650]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-02
• Device Publish Date: 2016-01-29

On-Brand Devices [Open Heart Pack]

• 00607567208650: BEQ-HMO 71000 Quadrox i Adult with integral filter VHK 71000 Venous Reservoir - uncoated BEQ-RF3
• 00607567204164: HMO 71000 (BO Coated) Quadrox i Adult with integral filter BO-VHK 71000 Venous Reservoir BO-RF32
• 00607567201194: BE-HMO 71000 VHK 71000 BEQ-RF32 BC 60 Plus BMU CEll Prebypass Filter Bacteria Filter Gas Fileter