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

• 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