Home GUDID B066201006NS1
CANNULAE, SAPHENOUS VEIN
Primary DI B066201006NS1
Brand CANNULAE, SAPHENOUS VEIN
Company NOVOSCI CORP.
Model 201006NS
Catalog number 201006NS
Device description A single lumen, tubular device designed to deliver cardioplegic solution to the aortic root to stop the beating of the heart and maintain it dormant; it may also be used to vent the aorta and the left heart during a cardiopulmonary bypass procedure. It is typically made of plastic [e.g., polypropylene, polyvinyl chloride (PVC)] with a soft insertion tip and a suture flange for its anchoring; it may have one or more tubes (a second for aspiration, if needed), and typically Luer connector(s) for connection to the infusion syringe and aspiration line(s). It may include a manual tubing clamp and insertion is typically achieved with a removable stylet. This is a single-use device.
Published 2015-11-11
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true
Product Codes# Code, Name table Code Name DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B066201006NS3 Package HIBCC 1000 In Commercial Distribution B066201006NS1 Primary HIBCC 0 B066201006NS0 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Cardioplegia cannula A sterile, single lumen, tubular device designed to deliver cardioplegic solution to the aortic root to stop the beating of the heart and maintain it dormant; it may also be used to vent the aorta and the left heart during a cardiopulmonary bypass procedure. It is typically made of plastic [e.g., polypropylene, polyvinyl chloride (PVC)] with a soft insertion tip and a suture flange for its anchoring; it may have one or more tubes (a second for aspiration, if needed), and typically Luer connector(s) for connection to the infusion syringe and aspiration line(s). It may include a manual tubing clamp and insertion is typically achieved with a removable stylet. This is a single-use device.
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 938289980 Device count 500 Premarket exempt true Lot or batch true Manufacturing date on label true Sterilization required before use true 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 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 B066332023NS1 "CONNECTOR, 1/4"" X 3/8"" W/O PART LINE W/LUER" 332023NS 332023NS 2015-10-13
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