ECC Pack 701062795

GUDID 00607567204447

Softshell Venous Reser. 1900ml,

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set 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	00607567204447
NIH Device Record Key	8ed5c728-bd2a-4caa-bb30-0d352d215c99
Commercial Distribution Status	In Commercial Distribution
Brand Name	ECC Pack
Version Model Number	BEQ-T 22101
Catalog Number	701062795
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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607567204447 [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

[00607567204447]

Ethylene Oxide

[00607567204447]

Ethylene Oxide

[00607567204447]

Ethylene Oxide

[00607567204447]

Ethylene Oxide

[00607567204447]

Ethylene Oxide

[00607567204447]

Ethylene Oxide

[00607567204447]

Ethylene Oxide

[00607567204447]

Ethylene Oxide

[00607567204447]

Ethylene Oxide

[00607567204447]

Ethylene Oxide

[00607567204447]

Ethylene Oxide

[00607567204447]

Ethylene Oxide

[00607567204447]

Ethylene Oxide

[00607567204447]

Ethylene Oxide

[00607567204447]

Ethylene Oxide

[00607567204447]

Ethylene Oxide

[00607567204447]

Ethylene Oxide

[00607567204447]

Ethylene Oxide

[00607567204447]

Ethylene Oxide

[00607567204447]

Ethylene Oxide

[00607567204447]

Ethylene Oxide

[00607567204447]

Ethylene Oxide

[00607567204447]

Ethylene Oxide

[00607567204447]

Ethylene Oxide

[00607567204447]

Ethylene Oxide

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-12-02
Device Publish Date	2017-03-28

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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
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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