Pediatric ECC Pack with QPID 701052843

GUDID 00607567205192

BEQ-HMOD 30000-USA Pediatric Quadrox Softshell Venous Reser 800 ml Better Bladder BEQ-RF32 RotaFlow CDI Sat Cell 1/4" Blood Microfilter Systes Prebypass filter w/o Vent Posous Media Gas Filter Temperature 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: 00607567205192
• NIH Device Record Key: 2f14b7a7-aa70-4918-be1e-33b7db115053
• Commercial Distribution Discontinuation: 2019-10-26
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Pediatric ECC Pack with QPID
• Version Model Number: BEQ-TOP 31000
• Catalog Number: 701052843
• 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

Customer Support Contacts

• Phone: 18886278383
• Email: cpsurgery@maquet.com
• Phone: 18886278383
• Email: cpsurgery@maquet.com
• Phone: 18886278383
• Email: cpsurgery@maquet.com
• Phone: 18886278383
• Email: cpsurgery@maquet.com
• Phone: 18886278383
• Email: cpsurgery@maquet.com
• Phone: 18886278383
• Email: cpsurgery@maquet.com
• Phone: 18886278383
• Email: cpsurgery@maquet.com
• Phone: 18886278383
• Email: cpsurgery@maquet.com
• Phone: 18886278383
• Email: cpsurgery@maquet.com
• Phone: 18886278383
• Email: cpsurgery@maquet.com
• Phone: 18886278383
• Email: cpsurgery@maquet.com

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	00607567205192 [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

[00607567205192]

Ethylene Oxide

[00607567205192]

Ethylene Oxide

[00607567205192]

Ethylene Oxide

[00607567205192]

Ethylene Oxide

[00607567205192]

Ethylene Oxide

[00607567205192]

Ethylene Oxide

[00607567205192]

Ethylene Oxide

[00607567205192]

Ethylene Oxide

[00607567205192]

Ethylene Oxide

[00607567205192]

Ethylene Oxide

[00607567205192]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-28
• Device Publish Date: 2015-11-13

On-Brand Devices [Pediatric ECC Pack with QPID]

• 00607567205192: BEQ-HMOD 30000-USA Pediatric Quadrox Softshell Venous Reser 800 ml Better Bladder BEQ-RF32 RotaF
• 00607567202580: BEQ HMOD 30000 BEQ-RF32 Pediatric Temp Probe