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

• 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