ECC 1/4" AV loop, RF and Q-iD 701054776R01

GUDID 00607567212480

BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, Blood Transfer Bag 1000 ml - 2 spike ports, BEQ-RF32 RotaFlow, CDI Sat Cell 1/4" System 100Blood Microfilter System SQ 40 S, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set

Primary Device ID	00607567212480
NIH Device Record Key	cf22fc74-c8ca-4b22-a59b-488c995725ba
Commercial Distribution Status	In Commercial Distribution
Brand Name	ECC 1/4" AV loop, RF and Q-iD
Version Model Number	BEQ-TOP 21503
Catalog Number	701054776R01
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	00607567212480 [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

[00607567212480]

Ethylene Oxide

[00607567212480]

Ethylene Oxide

[00607567212480]

Ethylene Oxide

[00607567212480]

Ethylene Oxide

[00607567212480]

Ethylene Oxide

[00607567212480]

Ethylene Oxide

[00607567212480]

Ethylene Oxide

[00607567212480]

Ethylene Oxide

[00607567212480]

Ethylene Oxide

[00607567212480]

Ethylene Oxide

[00607567212480]

Ethylene Oxide

[00607567212480]

Ethylene Oxide

[00607567212480]

Ethylene Oxide

[00607567212480]

Ethylene Oxide

[00607567212480]

Ethylene Oxide

[00607567212480]

Ethylene Oxide

[00607567212480]

Ethylene Oxide

[00607567212480]

Ethylene Oxide

[00607567212480]

Ethylene Oxide

[00607567212480]

Ethylene Oxide

[00607567212480]

Ethylene Oxide

[00607567212480]

Ethylene Oxide

[00607567212480]

Ethylene Oxide

[00607567212480]

Ethylene Oxide

[00607567212480]

Ethylene Oxide

[00607567212480]

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

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