Adult ECC 701054295R01

GUDID 00607567212404

BEQ-HNOD 70000-USA Adult QuadroxiD, Softshell Venous Reserv. 800ml, Better Bladder 3/8, CDI Sat Cell 3/8" System 100, 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 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: 00607567212404
• NIH Device Record Key: 40af49f7-194e-468f-bb8c-cc754c1805a5
• Commercial Distribution Discontinuation: 2019-10-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Adult ECC
• Version Model Number: BEQ-TOP 24202
• Catalog Number: 701054295R01
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607567212404 [Primary]

FDA Product Code

• DWE: Tubing, Pump, Cardiopulmonary Bypass

Sterilization

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

[00607567212404]

Ethylene Oxide

[00607567212404]

Ethylene Oxide

[00607567212404]

Ethylene Oxide

[00607567212404]

Ethylene Oxide

[00607567212404]

Ethylene Oxide

[00607567212404]

Ethylene Oxide

[00607567212404]

Ethylene Oxide

[00607567212404]

Ethylene Oxide

[00607567212404]

Ethylene Oxide

[00607567212404]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-06
• Device Publish Date: 2019-10-29

On-Brand Devices [Adult ECC]

• 00607567205499: BEQ-HMOD 70000 Better Bladder 3/8 CDI Sat Cell 3/8" Gas Filter
• 00607567203655: BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, Better Bladder 3/8, SAT/CRIT
• 00607567203037: BEQ-HMOD 70000 Softshell venous reservoir 800 ml CDI Sat cell 3/8" Blood Microfilter system Preb
• 00607567212404: BEQ-HNOD 70000-USA Adult QuadroxiD, Softshell Venous Reserv. 800ml, Better Bladder 3/8, CDI Sat
• 00607567213111: BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, CDI Sai Cell 3/8" System 100