Tubing Pack 701052324

GUDID 00607567203952

BO-RF32 Rotaflow

DATASCOPE CORP.

Cardiopulmonary bypass system centrifugal pump

• Primary Device ID: 00607567203952
• NIH Device Record Key: 853262c5-f887-4c71-92be-101391db132c
• Commercial Distribution Discontinuation: 2018-12-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Tubing Pack
• Version Model Number: BO-T 6600
• Catalog Number: 701052324
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607567203952 [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

[00607567203952]

Ethylene Oxide

[00607567203952]

Ethylene Oxide

[00607567203952]

Ethylene Oxide

[00607567203952]

Ethylene Oxide

[00607567203952]

Ethylene Oxide

[00607567203952]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-12-02
• Device Publish Date: 2015-10-30

On-Brand Devices [Tubing Pack]

• 00607567212503: BEQ-HMOD 70000-USAAdult Quadrox iD, BEQ-RF32 Rotaflow, CDI SAT Cell 3/8" System 100, Gas Filter
• 00607567203952: BO-RF32 Rotaflow
• 00607567200760: BEQ-HMOD 70000-USA Adult Quadrox iD Blood Microfilter System SQ 40 S
• 00607567200296: BEQ-HMOD 700000 BEQ-RF32 CDI Sat Cell 3/8" Gas Filter