Adult Custom Pack 701054438R01

GUDID 00607567212237

BEQ-HMOD 70000-USA Adult Quadrox iD, BEQ-RF32 RotaFlow, Gas Filter

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set

• Primary Device ID: 00607567212237
• NIH Device Record Key: 242b2330-0254-4e93-94df-9c1b8ffc95e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adult Custom Pack
• Version Model Number: BEQ-TOP 32100
• Catalog Number: 701054438R01
• 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	00607567212237 [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

[00607567212237]

Ethylene Oxide

[00607567212237]

Ethylene Oxide

[00607567212237]

Ethylene Oxide

[00607567212237]

Ethylene Oxide

[00607567212237]

Ethylene Oxide

[00607567212237]

Ethylene Oxide

[00607567212237]

Ethylene Oxide

[00607567212237]

Ethylene Oxide

[00607567212237]

Ethylene Oxide

[00607567212237]

Ethylene Oxide

[00607567212237]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-12-02
• Device Publish Date: 2018-05-09

On-Brand Devices [Adult Custom Pack]

• 00607567212237: BEQ-HMOD 70000-USA Adult Quadrox iD, BEQ-RF32 RotaFlow, Gas Filter
• 00607567211575: Softshell Venous Reser. 1900ml w. connector 700000292, BEQ-RF32 RotaFlow, Gas Filter
• 00607567202993: 701053325 BEQ-HMOD 70000-USA Adult Quadrox iD 701020489 BEQ-RF32 RotaFlow 701045763 Gas Filter
• 00607567213319: BEQ-HMOD 70000-USA Adult Quadrox iD, BEQ-RF32 RotaFlow, Gas Filter