Home GUDID B0663014000007 PRESSURE GUAGE ISOLATOR KIT
Primary DI B0663014000007
Brand PRESSURE GUAGE 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 potenti
Published 2015-10-09
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name DXS Gauge, Pressure, Coronary, Cardiopulmonary Bypass
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DXS Gauge, Pressure, Coronary, Cardiopulmonary Bypass Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B0663014000003 Package HIBCC 25 In Commercial Distribution B0663014000005 Package HIBCC 100 In Commercial Distribution B0663014000006 Package HIBCC 50 In Commercial Distribution B0663014000007 Package HIBCC 75 In Commercial Distribution B0663014000000 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Cardiopulmonary bypass system filter, arterial blood line 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.
Regulatory Flags# DUNS number 938289980 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex true No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B0662010110000 STOPCOCK, TMP 3-WAY W/LUER LOCK 201011-000 201011-000 2015-09-14 B0662010120000 STOPCOCK, TMP 4-WAY W/LUER LOCK 201012-000 201012-000 2015-09-14 B0663110330000 TUBING ORGANIZER - STERILE 311033-000 311033-000 2015-10-06 B066311033NS1 TUBING ORGANIZER - NON-STERILE 311033NS 311033NS 2015-10-13 B0663110340000 PEDIATRIC TUBING ORGANIZER - STERILE 311034-000 311034-000 2015-10-12 B066311034NS1 PEDIATRIC TUBING ORGANIZRER - NON-STERILE 311034NS 311034NS 2015-10-13 B066321244NS1 "CONNECTOR, 1/4"" X 1/2"" X 1/2"" CLEAR PAY " 321244NS 321244NS 2015-10-13 B066201006NS1 CANNULAE, SAPHENOUS VEIN 201006NS 201006NS 2015-11-11 B066301011NS1 "QUICKIE PRIME - 1/4"" x 1/16""" 301011NS 301011NS 2017-12-06 B066331011NS1 "CONNECTOR, 3/16"" X 3/16"" W/OUT PART LINE " 331011NS 331011NS 2015-10-13 B066331012NS1 "CONNECTOR, 3/16"" X 1/4"" W/OUT PART LINE" 331012NS 331012NS 2015-10-13 B066331022NS1 "CONNECTOR, 1/4"" X 1/4"" W/OUT PART LINE" 331022NS 331022NS 2015-10-13 B066331023NS1 "CONNECTOR, 1/4"" X 3/8"" W/OUT PART LINE" 331023NS 331023NS 2015-10-13 B066331024NS1 "CONNECTOR, 1/4"" X 1/2"" W/OUT LUER " 331024NS 331024NS 2015-10-13 B066331033NS1 "CONNECTOR, 3/8"" X 3/8"" W/OUT PART LINE" 331033NS 331033NS 2015-10-13 B066331034NS1 "CONNECTOR, 3/8"" X 1/2"" W/OUT PART LINE" 331034NS 331034NS 2015-10-13 B066331044NS1 "CONNECTOR, 1/2"" X 1/2"" W/OUT PART LINE" 331044NS 331044NS 2015-10-13 B066332011NS1 "CONNECTOR, 3/16"" X 3/16"" W/OUT PART LINE W/LUER" 332011NS 332011NS 2015-10-13 B066332012NS1 "CONNECTOR, 3/16"" X 1/4"" W/OUT PART LINE W/LUER" 332012NS 332012NS 2015-10-13 B066332022NS1 "CONNECTOR, 1/4"" X 1/4"" W/LUER" 332022NS 332022NS 2015-10-13
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 20763000946504 DLP® MEDTRONIC, INC. DXS 2024-07-18 00763000946500 DLP® MEDTRONIC, INC. DXS 2024-07-18 20643169880959 DLP® MEDTRONIC, INC. DXS 2019-03-03 20613994846604 DLP® MEDTRONIC, INC. DXS 2016-06-13 20613994846628 DLP® MEDTRONIC, INC. DXS 2016-06-13 20613994846642 DLP® MEDTRONIC, INC. DXS 2016-06-13 20613994846666 DLP® MEDTRONIC, INC. DXS 2016-06-13 00643169200999 NA MEDTRONIC, INC. DXS 2016-04-28 B0663014000000 PRESSURE GAUGE ISOLATOR KIT NOVOSCI CORP. DXS 2015-10-09
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