FDA.reportPublic FDA data

"LVAD 1/4"""

Primary DI
00607567212909
Brand
"LVAD 1/4"""
Company
DATASCOPE CORP.
Model
BEQ-T 3502
Catalog number
701068168R02
Device description
"Softshell Venous Reser. 800ml, BEQ-RF32 RotaFlow, CDI Sat Cell 1/4"" System 100, Blood Microfilter System SQ 40 S, Gas Filter "
Published
2019-05-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DWETubing, Pump, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWETubing, Pump, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00607567212909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00607567212909006075672129096075672129090607567212909

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system tubing setA collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
001660786
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10607567106656Reinforced Introducer Set for Linear 7.5Fr & Mega 7.5Fr0684-00-0403-050684-00-0403-052023-03-14
10607567106694Reinforced Introducer Set for Sensation 7Fr0684-00-0403-060684-00-0403-062023-03-14
10607567107943Reinforced Introducer Set for Sensation Plus & Mega 8Fr0684-00-0403-100684-00-0403-102023-03-14
10607567510996TigerPaw Pro Left Atrial Appendage Closure Device35mm7500010992020-11-18
10607567107301MEGA 8Fr. 50cc IAB0684-00-0498-010684-00-0498-012016-09-15
10607567107318MEGA 8Fr. 50cc IAB (with APA)0684-00-0498-020684-00-0498-022016-09-15
10607567107479Arrow Pump Adapter - 5 Pack - for use with the Mega 8 Fr. 50cc IAB only0684-00-0510-020684-00-0510-022016-09-23
10607567107516Catheter Extenders for 50cc IAB’s 0684-00-05260684-00-05262016-09-14
10607567108001MEGA 8Fr. 50cc IAB (with Statlock)0684-00-0296-010684-00-0296-012016-09-15
10607567108018MEGA 8Fr. 50cc IAB (with Statlock & APA)0684-00-0296-020684-00-0296-022016-09-15
10607567108063SENSATION PLUS 7.5Fr. 40cc IAB & Accessories0684-00-0568-010684-00-0568-012016-09-15
10607567108605SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet)0684-00-0576-010684-00-0576-012016-09-15
10607567109381Sensation Plus 8Fr 50cc IAB With Accessories (w/Pressure Tubes, No Stylet, w/o S0684-00-0576-050684-00-0576-052016-09-15
10607567109411MEGA 8Fr. 50cc IAB (W/O Statlock)0684-00-0296-030684-00-0296-032016-09-15
10607567109428Sensation Plus 7.5Fr. 40cc IAB (W/O Statlock)0684-00-0568-030684-00-0568-032016-09-15
10607567109435Sensation Plus 8Fr. 50cc IAB (W/O Statlock)0684-00-0576-030684-00-0576-032016-09-15
10607567109442Sensation Plus 7.5Fr. 40cc IAB W/ Accessories (W/O Statlock)(China)0684-00-0568-050684-00-0568-052016-09-15
10607567109565Sensation Plus 7.5Fr. 40cc IAB with Accessories, US Only0684-00-0568-01U0684-00-0568-01U2016-09-15
10607567109619MEGA 8Fr. 50cc IAB with Accessories, US Only0684-00-0296-01U0684-00-0296-01U2016-09-16
10607567109626MEGA 8Fr. 50cc IAB with Accessories (APA), US Only0684-00-0296-02U0684-00-0296-02U2016-09-16

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