ECC Pack 701063721R01

GUDID 00607567212572

BEQ-HMOD 70000-USA Adult Quadrox iD, BEQ-RF32 RotaFlow,CDI Sat Cell 3/8" System 100 , Gas Filter

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set

• Primary Device ID: 00607567212572
• NIH Device Record Key: 6112367f-594d-4637-8552-affdaeba8550
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECC Pack
• Version Model Number: BEQ-TOP 43100
• Catalog Number: 701063721R01
• 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

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
• 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
• 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
• 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
• 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	00607567212572 [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

[00607567212572]

Ethylene Oxide

[00607567212572]

Ethylene Oxide

[00607567212572]

Ethylene Oxide

[00607567212572]

Ethylene Oxide

[00607567212572]

Ethylene Oxide

[00607567212572]

Ethylene Oxide

[00607567212572]

Ethylene Oxide

[00607567212572]

Ethylene Oxide

[00607567212572]

Ethylene Oxide

[00607567212572]

Ethylene Oxide

[00607567212572]

Ethylene Oxide

[00607567212572]

Ethylene Oxide

[00607567212572]

Ethylene Oxide

[00607567212572]

Ethylene Oxide

[00607567212572]

Ethylene Oxide

[00607567212572]

Ethylene Oxide

[00607567212572]

Ethylene Oxide

[00607567212572]

Ethylene Oxide

[00607567212572]

Ethylene Oxide

[00607567212572]

Ethylene Oxide

[00607567212572]

Ethylene Oxide

[00607567212572]

Ethylene Oxide

[00607567212572]

Ethylene Oxide

[00607567212572]

Ethylene Oxide

[00607567212572]

Ethylene Oxide

[00607567212572]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-02
• Device Publish Date: 2018-07-19

On-Brand Devices [ECC Pack]

• 00607567212572: BEQ-HMOD 70000-USA Adult Quadrox iD, BEQ-RF32 RotaFlow,CDI Sat Cell 3/8" System 100 , Gas Filter
• 00607567212282: BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 1900ml, BEQ-RF32 RotaFlow, Gas Filt
• 00607567212145: BEQ-HMOD 70000-USA Adult Quadrox iD, BEQ-RF32 RotaFlow, BMU Cell Ven. 3/8, Arterial Sensor 3/8"
• 00607567211520: Softshell Venous Reser. 1900ml w. connector 700000292, BEQ-RF32 RotaFlow, Gas Filter
• 00607567209664: BO-HMOD 70000-USA Adult Quadrox iD, BO-RF32 RotaFlow, Gas Filter.
• 00607567208551: BO-VHK 11000 Venous Res. Pediatric (MACE) BEQ-RF32 RotaFlow Blood Microfilter System SQ 40 S Pre
• 00607567207783: BEQ-HMOD 30000-USA Pediatric Quadrox iD, Softshell Venous Reser. 800ml, Better Bladder 1/4, HPH
• 00607567206601: BEQ-HMOD 70000-USA Adult Quadrox iD BEQ-RF32 RotaFlow CDI Sat Cell 3/8" System 100 Gas Filter
• 00607567204485: Gas Filter
• 00607567204447: Softshell Venous Reser. 1900ml,
• 00607567204355: BEQ-RF32 RotaFlow Gas Filter
• 00607567204348: BEQ HMOD 70000 BEQ RF32 Gas FIlter
• 00607567203419: BEQ-RF32
• 00607567203358: BEQ-HMOD 70000-USA Adult Quadrox iD, BO-VHK 71000 Venous Reservoir, BEQ-RF32 RotaFlow, Gas Filte
• 00607567202917: BEQ-HMOD 70000-USA Adult Quadrox iD FlowProbe Connector
• 00607567213333: BEQ-HMOD 30000-USA Pediatric Quadrox iD, Softshell Venous Reser. 800ml, BC 60 plus, BMU Cell Ven