ECC Pack 3/8 with Rotaflow 701065622R01

GUDID 00607567212763

BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, Better Bladder 3/8, BEQ-RF32 RotaFlow, BC 60 plus,Blood Microfilter System SQ 40 S, Prebypass filter w/o Vent Porous Media 3/8x3/8, Temperature Probe,

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set

• Primary Device ID: 00607567212763
• NIH Device Record Key: 7a3d7687-4cae-4d16-8ada-29c246b86af1
• Commercial Distribution Discontinuation: 2019-06-12
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ECC Pack 3/8 with Rotaflow
• Version Model Number: BEQ-TOP 27610
• Catalog Number: 701065622R01
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607567212763 [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

[00607567212763]

Ethylene Oxide

[00607567212763]

Ethylene Oxide

[00607567212763]

Ethylene Oxide

[00607567212763]

Ethylene Oxide

[00607567212763]

Ethylene Oxide

[00607567212763]

Ethylene Oxide

[00607567212763]

Ethylene Oxide

[00607567212763]

Ethylene Oxide

[00607567212763]

Ethylene Oxide

[00607567212763]

Ethylene Oxide

[00607567212763]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-06-12
• Device Publish Date: 2018-12-05

On-Brand Devices [ECC Pack 3/8 with Rotaflow]

• 00607567212763: BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, Better Bladder 3/8, BEQ-RF32
• 00607567205642: BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, Better Bladder 3/8, BEQ-RF32