ECC 3/8" AV loop, RF and Q-iD 701064505R01

GUDID 00607567212473

BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, Blood Transfer Bag 1000 ml - 2 spike ports, BEQ-RF32 RotaFlow, CDI Sat Cell 3/8" System 100, Blood Microfilter System SQ 40 S, Prebypass filter w/o Vent Porous Media 3/8x3/8

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set

• Primary Device ID: 00607567212473
• NIH Device Record Key: a00e08ba-bc43-4f21-b551-7b530f8e0cc8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECC 3/8" AV loop, RF and Q-iD
• Version Model Number: BEQ-TOP 21506
• Catalog Number: 701064505R01
• 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

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	00607567212473 [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

[00607567212473]

Ethylene Oxide

[00607567212473]

Ethylene Oxide

[00607567212473]

Ethylene Oxide

[00607567212473]

Ethylene Oxide

[00607567212473]

Ethylene Oxide

[00607567212473]

Ethylene Oxide

[00607567212473]

Ethylene Oxide

[00607567212473]

Ethylene Oxide

[00607567212473]

Ethylene Oxide

[00607567212473]

Ethylene Oxide

[00607567212473]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-02
• Device Publish Date: 2018-07-19

On-Brand Devices [ECC 3/8" AV loop, RF and Q-iD]

• 00607567212473: BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, Blood Transfer Bag 1000 ml -
• 00607567205123: BEQ-HMOD 70000-USA Adult Quadrox iD Softshell Venous Reser. 800ml Blood Transfer Bag 1000 ml - 2