Small Adult Open Heart Pack 709000168

GUDID 00607567208223

HMO 51000 (BO coated) Quadrox i Small Adult with integral filter, BO-VHK 71000 Venous Reservoir, Blood Transfer Bag 1000 ml - 2 spike ports, BO-RF32 RotaFlow, BC 60 plus, CDI Sat Cell 3/8" System 100, Prebypass filter w/o Vent Porous Media 3/8x1/2, Gas Filter

DATASCOPE CORP.

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• Primary Device ID: 00607567208223
• NIH Device Record Key: 5ce376ee-5a93-4da5-ab84-8ee43ffcdb5e
• Commercial Distribution Discontinuation: 2018-07-20
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Small Adult Open Heart Pack
• Version Model Number: BO-TOP 40013
• Catalog Number: 709000168
• 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	00607567208223 [Primary]

FDA Product Code

• DWF: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00607567208223]

Ethylene Oxide

[00607567208223]

Ethylene Oxide

[00607567208223]

Ethylene Oxide

[00607567208223]

Ethylene Oxide

[00607567208223]

Ethylene Oxide

[00607567208223]

Ethylene Oxide

[00607567208223]

Ethylene Oxide

[00607567208223]

Ethylene Oxide

[00607567208223]

Ethylene Oxide

[00607567208223]

Ethylene Oxide

[00607567208223]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-01-28
• Device Publish Date: 2016-12-15

On-Brand Devices [Small Adult Open Heart Pack ]

• 00607567208223: HMO 51000 (BO coated) Quadrox i Small Adult with integral filter, BO-VHK 71000 Venous Reservoir,
• 00607567207882: BEQ-HMO 51000 Quadrox i Small Adult with integral filter, BO-VHK 71000 Venous Reservoir, Blood T