Circulatory ECC 701051791

GUDID 00607567202016

BEW HMOD 70000 BEQ RF32 BMY CEll Arterial Sensor Gas Filter

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set

• Primary Device ID: 00607567202016
• NIH Device Record Key: fac4e770-a4c6-4cb3-9faf-266174904a9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Circulatory ECC
• Version Model Number: BEQ T 5502
• Catalog Number: 701051791
• 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 Fahrenheit and 30 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Fahrenheit and 30 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607567202016 [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

[00607567202016]

Ethylene Oxide

[00607567202016]

Ethylene Oxide

[00607567202016]

Ethylene Oxide

[00607567202016]

Ethylene Oxide

[00607567202016]

Ethylene Oxide

[00607567202016]

Ethylene Oxide

[00607567202016]

Ethylene Oxide

[00607567202016]

Ethylene Oxide

[00607567202016]

Ethylene Oxide

[00607567202016]

Ethylene Oxide

[00607567202016]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-02
• Device Publish Date: 2016-01-04

On-Brand Devices [Circulatory ECC]

• 00607567207622: BEQ-RF32 RotaFlow 4037691027234
• 00607567202016: BEW HMOD 70000 BEQ RF32 BMY CEll Arterial Sensor Gas Filter