3/8 by 3/8 Pack 701065913

GUDID 00060756720554

BEQ HMOD 70000 Soft Shell Venous Reser Blood Microfilter System Prebypass Filter Gas Filter

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set

• Primary Device ID: 00060756720554
• NIH Device Record Key: 14e5445e-2d11-4338-b283-79b03dbed410
• Commercial Distribution Discontinuation: 2018-05-23
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: 3/8 by 3/8 Pack
• Version Model Number: BEQ TOP 8503
• Catalog Number: 701065913
• Company DUNS: 001660786
• Company Name: DATASCOPE CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does n
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00060756720554 [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

[00060756720554]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-01-04

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