Small Patient ECC Pack 701050175R02

GUDID 00607567208865

BEQ-HMOD 30000-USA Pediatric Quadrox iD Blood Transfer Bag 1000 ml - 2 spike ports BEQ-RF32 RotaFlow BMU Cell Ven. 1/4 Arterial Sensor 1/4" (BMU) Blood Microfilter System SQ 40 S Gas Filter

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set

• Primary Device ID: 00607567208865
• NIH Device Record Key: ca1350aa-0229-42c1-9635-c525148ef1b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Small Patient ECC Pack
• Version Model Number: BEQ-TOP 24100
• Catalog Number: 701050175R02
• 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
• 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
• 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
• 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
• 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	00607567208865 [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

[00607567208865]

Ethylene Oxide

[00607567208865]

Ethylene Oxide

[00607567208865]

Ethylene Oxide

[00607567208865]

Ethylene Oxide

[00607567208865]

Ethylene Oxide

[00607567208865]

Ethylene Oxide

[00607567208865]

Ethylene Oxide

[00607567208865]

Ethylene Oxide

[00607567208865]

Ethylene Oxide

[00607567208865]

Ethylene Oxide

[00607567208865]

Ethylene Oxide

[00607567208865]

Ethylene Oxide

[00607567208865]

Ethylene Oxide

[00607567208865]

Ethylene Oxide

[00607567208865]

Ethylene Oxide

[00607567208865]

Ethylene Oxide

[00607567208865]

Ethylene Oxide

[00607567208865]

Ethylene Oxide

[00607567208865]

Ethylene Oxide

[00607567208865]

Ethylene Oxide

[00607567208865]

Ethylene Oxide

[00607567208865]

Ethylene Oxide

[00607567208865]

Ethylene Oxide

[00607567208865]

Ethylene Oxide

[00607567208865]

Ethylene Oxide

[00607567208865]

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: 2016-03-17

On-Brand Devices [Small Patient ECC Pack]

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• 00607567208865: BEQ-HMOD 30000-USA Pediatric Quadrox iD Blood Transfer Bag 1000 ml - 2 spike ports BEQ-RF32 Rota
• 00607567208636: BEQ-HMOD 30000-USA Pediatric Quadrox iD Blood Transfer Bag 1000 ml - 2 spike ports BEQ-RF32 Rota
• 00607567202504: BEQ HMOD 30000 Blood Transfer Bag BEQ- RF32 CDI Sat cell Blood Microfilter system Gas Filter Ped
• 00607567202061: BEQ- HMDOD 70000 Soft Shell Venous Reser 800mL Better Bladder 1/4 BEQ RF 32 Rotaflow Gas Filter
• 00607567213258: BEQ-HMOD 30000-USA Pediatric Quadrox iD, Blood Transfer Bag 1000 ml - 2 spike ports,Blood Microf