ECC 3/8" Pack 701053845

GUDID 00607567203167

BEQ HMOD 70000 Softshell Venous Reser Better Bladder BEQ RF 32 Blood Microfilter Prebypass filter Gas Filter

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set

• Primary Device ID: 00607567203167
• NIH Device Record Key: c70925e5-52a9-44c6-a8cd-bd25550d3a66
• Commercial Distribution Discontinuation: 2019-06-12
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ECC 3/8" Pack
• Version Model Number: BEQ-TOP 33700
• Catalog Number: 701053845
• 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

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	00607567203167 [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

[00607567203167]

Ethylene Oxide

[00607567203167]

Ethylene Oxide

[00607567203167]

Ethylene Oxide

[00607567203167]

Ethylene Oxide

[00607567203167]

Ethylene Oxide

[00607567203167]

Ethylene Oxide

[00607567203167]

Ethylene Oxide

[00607567203167]

Ethylene Oxide

[00607567203167]

Ethylene Oxide

[00607567203167]

Ethylene Oxide

[00607567203167]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-12
• Device Publish Date: 2016-01-15

On-Brand Devices [ECC 3/8" Pack]

• 00607567212220: BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, Better Bladder 1/4, BEQ-RF32
• 00607567203167: BEQ HMOD 70000 Softshell Venous Reser Better Bladder BEQ RF 32 Blood Microfilter Prebypass filt