Pediatric Specialty Pack 701062899

GUDID 00607567204850

BEQ HMOD 30000 Soft Shell Venous Reserv 800ml Better Bladder 1/4 Blood Microfilter Syst Prebypass filter Gas Filter Pediatric Temp Probe

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set

• Primary Device ID: 00607567204850
• NIH Device Record Key: eab28d24-aa51-4c51-9cb7-71e62f34692f
• Commercial Distribution Discontinuation: 2019-06-12
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Pediatric Specialty Pack
• Version Model Number: BEQ TOP 40700
• Catalog Number: 701062899
• 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	00607567204850 [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

[00607567204850]

Ethylene Oxide

[00607567204850]

Ethylene Oxide

[00607567204850]

Ethylene Oxide

[00607567204850]

Ethylene Oxide

[00607567204850]

Ethylene Oxide

[00607567204850]

Ethylene Oxide

[00607567204850]

Ethylene Oxide

[00607567204850]

Ethylene Oxide

[00607567204850]

Ethylene Oxide

[00607567204850]

Ethylene Oxide

[00607567204850]

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: 2016-02-14

On-Brand Devices [Pediatric Specialty Pack]

• 00607567212800: BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 1900ml, Better Bladder 3/8, BEQ-RF3
• 00607567206144: BEQ-HMOD 70000 Softshell Venous Reser Better Bladder 3/8 BEQ-RF32 Rotaflow CDI Sat Cell 3/8 Syst
• 00607567204850: BEQ HMOD 30000 Soft Shell Venous Reserv 800ml Better Bladder 1/4 Blood Microfilter Syst Prebypas
• 00607567204607: BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, BEQ-RF32 RotaFlow, CDI Sat C