PRESSURE GAUGE ISOLATOR KIT

Primary DI
B0663014000000
Brand
PRESSURE GAUGE ISOLATOR KIT
Company
NOVOSCI CORP.
Model
301400-000
Catalog number
301400-000
Device description
A sterile, porous device used in the arterial line of an extracorporeal circuit, during a cardiopulmonary bypass procedure, to trap and remove potentially harmful gaseous emboli, aggregated blood constituents, and particles greater than a specified size (e.g., 40 microns) to prevent them from flowing into the bloodstream and obstructing extracorporeal circulation. It is commonly referred to as a bubble trap and will typically be used for a specified length of time (e.g., 6 hours). This is a single-use device.
Published
2015-10-09
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXSGauge, Pressure, Coronary, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXSGauge, Pressure, Coronary, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K912045000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K912045000TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYSTLifestream Int'L, Inc.1991-10-31DXS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B0663014000003PackageHIBCC25In Commercial Distribution
B0663014000005PackageHIBCC100In Commercial Distribution
B0663014000006PackageHIBCC50In Commercial Distribution
B0663014000007PackageHIBCC75In Commercial Distribution
B0663014000000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system filter, arterial blood lineA sterile, porous device used in the arterial line of an extracorporeal circuit, during a cardiopulmonary bypass procedure, to trap and remove potentially harmful gaseous emboli, aggregated blood constituents, and particles greater than a specified size (e.g., 40 microns) to prevent them from flowing into the bloodstream and obstructing extracorporeal circulation. It is commonly referred to as a bubble trap and will typically be used for a specified length of time (e.g., 6 hours). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
800-854-0567info@novosci.com

Regulatory Flags#

DUNS number
938289980
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B0662010110000STOPCOCK, TMP 3-WAY W/LUER LOCK201011-000201011-0002015-09-14
B0662010120000STOPCOCK, TMP 4-WAY W/LUER LOCK201012-000201012-0002015-09-14
B0663110330000TUBING ORGANIZER - STERILE311033-000311033-0002015-10-06
B066311033NS1TUBING ORGANIZER - NON-STERILE 311033NS311033NS2015-10-13
B0663110340000PEDIATRIC TUBING ORGANIZER - STERILE311034-000311034-0002015-10-12
B066311034NS1PEDIATRIC TUBING ORGANIZRER - NON-STERILE311034NS311034NS2015-10-13
B066321244NS1"CONNECTOR, 1/4"" X 1/2"" X 1/2"" CLEAR PAY "321244NS321244NS2015-10-13
B066201006NS1CANNULAE, SAPHENOUS VEIN201006NS201006NS2015-11-11
B066301011NS1"QUICKIE PRIME - 1/4"" x 1/16"""301011NS301011NS2017-12-06
B066331011NS1"CONNECTOR, 3/16"" X 3/16"" W/OUT PART LINE "331011NS331011NS2015-10-13
B066331012NS1"CONNECTOR, 3/16"" X 1/4"" W/OUT PART LINE"331012NS331012NS2015-10-13
B066331022NS1"CONNECTOR, 1/4"" X 1/4"" W/OUT PART LINE"331022NS331022NS2015-10-13
B066331023NS1"CONNECTOR, 1/4"" X 3/8"" W/OUT PART LINE"331023NS331023NS2015-10-13
B066331024NS1"CONNECTOR, 1/4"" X 1/2"" W/OUT LUER "331024NS331024NS2015-10-13
B066331033NS1"CONNECTOR, 3/8"" X 3/8"" W/OUT PART LINE"331033NS331033NS2015-10-13
B066331034NS1"CONNECTOR, 3/8"" X 1/2"" W/OUT PART LINE"331034NS331034NS2015-10-13
B066331044NS1"CONNECTOR, 1/2"" X 1/2"" W/OUT PART LINE"331044NS331044NS2015-10-13
B066332011NS1"CONNECTOR, 3/16"" X 3/16"" W/OUT PART LINE W/LUER"332011NS332011NS2015-10-13
B066332012NS1"CONNECTOR, 3/16"" X 1/4"" W/OUT PART LINE W/LUER"332012NS332012NS2015-10-13
B066332022NS1"CONNECTOR, 1/4"" X 1/4"" W/LUER"332022NS332022NS2015-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20763000946504DLP®MEDTRONIC, INC.DXS2024-07-18
00763000946500DLP®MEDTRONIC, INC.DXS2024-07-18
20643169880959DLP®MEDTRONIC, INC.DXS2019-03-03
20613994846604DLP®MEDTRONIC, INC.DXS2016-06-13
20613994846628DLP®MEDTRONIC, INC.DXS2016-06-13
20613994846642DLP®MEDTRONIC, INC.DXS2016-06-13
20613994846666DLP®MEDTRONIC, INC.DXS2016-06-13
00643169200999NAMEDTRONIC, INC.DXS2016-04-28
B0663014000007PRESSURE GUAGE ISOLATOR KITNOVOSCI CORP.DXS2015-10-09