Open heart pack no plegiox 701067364

GUDID 00607567206304

BEQ-HMOD 71000 BO-VHK 71000 Blood Transfer Bag 1000 BEQ- RF Rotaflow BC 60plus cdi SAT 1/2" prebypass filter gas filter

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set

• Primary Device ID: 00607567206304
• NIH Device Record Key: bb4adcea-b29a-4e49-a9c5-06cdb49ea22e
• Commercial Distribution Discontinuation: 2017-04-12
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Open heart pack no plegiox
• Version Model Number: BEQ-TOP 40010
• Catalog Number: 701067364
• 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

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	00607567206304 [Primary]

FDA Product Code

• DWE: Tubing, Pump, Cardiopulmonary Bypass

Sterilization

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

[00607567206304]

Ethylene Oxide

[00607567206304]

Ethylene Oxide

[00607567206304]

Ethylene Oxide

[00607567206304]

Ethylene Oxide

[00607567206304]

Ethylene Oxide

[00607567206304]

Ethylene Oxide

[00607567206304]

Ethylene Oxide

[00607567206304]

Ethylene Oxide

[00607567206304]

Ethylene Oxide

[00607567206304]

Ethylene Oxide

[00607567206304]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-11-02

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