Adult ECC Pack 701050177R01

GUDID 00607567208643

BEQ-HMOD 70000-USA Adult Quadrox iD Blood Transfer Bag 1000 ml - 2 spike ports BEQ-RF32 RotaFlow BMU Cell Ven. 3/8 Arterial Sensor 3/8" (BMU) Blood Microfilter System SQ 40 S Gas Filter Pediatric Temp Probe

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 00607567208643
• NIH Device Record Key: 5648873a-315d-4589-9921-a73064f0c2c0
• Commercial Distribution Discontinuation: 2018-12-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Adult ECC Pack
• Version Model Number: BEQ-TOP 24101
• Catalog Number: 701050177R01
• 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	00607567208643 [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

[00607567208643]

Ethylene Oxide

[00607567208643]

Ethylene Oxide

[00607567208643]

Ethylene Oxide

[00607567208643]

Ethylene Oxide

[00607567208643]

Ethylene Oxide

[00607567208643]

Ethylene Oxide

[00607567208643]

Ethylene Oxide

[00607567208643]

Ethylene Oxide

[00607567208643]

Ethylene Oxide

[00607567208643]

Ethylene Oxide

[00607567208643]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-12-02
• Device Publish Date: 2016-01-29

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• 00607567211919: BO-HMOD 70000-USA Adult Quadrox iD, BO-RF32 RotaFlow, Gas Filter
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• 00607567207844: BEQ HMOD 70000 BO VHK 31000 BO RF 32 SAT/CRIT Gas Filter
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• 00607567213012: BEQ-HMOD 70000-USA Adult Quadrox iD, Venous Bag Reservoir 1900, BEQ-RF32 RotaFlow, Blood Microfi