ECC Pack No Pediatric Quadrox 701067094

GUDID 00060756720619

Better Bladder 1/4, Blood Microfilter System SQ 40 S, Prebypass filter w/o Vent Porous Media 3/8x3/8 and Pediatric Temp Probe.

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set

• Primary Device ID: 00060756720619
• NIH Device Record Key: eb9d627a-c5e8-4e3e-9e07-5e5c6c53a431
• Commercial Distribution Discontinuation: 2017-09-20
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ECC Pack No Pediatric Quadrox
• Version Model Number: BEQ-T 49100
• Catalog Number: 701067094
• 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: false
• Labeled No Natural Rubber Latex: true
• 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	00060756720619 [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

[00060756720619]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-05-06

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