LVAD 1/4" 701068168R02

GUDID 00607567212909

Softshell Venous Reser. 800ml, BEQ-RF32 RotaFlow, CDI Sat Cell 1/4" System 100, Blood Microfilter System SQ 40 S, Gas Filter

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set

• Primary Device ID: 00607567212909
• NIH Device Record Key: e96fc927-bc3a-4650-a668-f8e69fc88600
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LVAD 1/4"
• Version Model Number: BEQ-T 3502
• Catalog Number: 701068168R02
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607567212909 [Primary]

FDA Product Code

• DWE: Tubing, Pump, Cardiopulmonary Bypass

Sterilization

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

[00607567212909]

Ethylene Oxide

[00607567212909]

Ethylene Oxide

[00607567212909]

Ethylene Oxide

[00607567212909]

Ethylene Oxide

[00607567212909]

Ethylene Oxide

[00607567212909]

Ethylene Oxide

[00607567212909]

Ethylene Oxide

[00607567212909]

Ethylene Oxide

[00607567212909]

Ethylene Oxide

[00607567212909]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-22
• Device Publish Date: 2019-05-14

On-Brand Devices [LVAD 1/4"]

• 00607567211797: Softshell Venous Reser. 800ml, BEQ-RF32 RotaFlow, BC 60 plus , CDI Sat Cell 1/4" System 100, Blo
• 00607567212909: Softshell Venous Reser. 800ml, BEQ-RF32 RotaFlow, CDI Sat Cell 1/4" System 100, Blood Microfilte