Home GUDID B0664110080007 EXTENSION LINE W/16GA MODIFIED NEEDLE
Primary DI B0664110080007
Brand EXTENSION LINE W/16GA MODIFIED NEEDLE
Company NOVOSCI CORP.
Model 411008-000
Catalog number 411008-000
Device description A sterile device designed to facilitate/regulate the delivery of cardioplegic solution to the heart during a cardiopulmonary bypass procedure by conne
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 DTR Heat-Exchanger, Cardiopulmonary Bypass
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DTR Heat-Exchanger, Cardiopulmonary Bypass Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B0664110080003 Package HIBCC 25 In Commercial Distribution B0664110080005 Package HIBCC 100 In Commercial Distribution B0664110080006 Package HIBCC 50 In Commercial Distribution B0664110080007 Package HIBCC 75 In Commercial Distribution B0664110080000 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Cardioplegia solution administration adaptor A sterile device designed to facilitate/regulate the delivery of cardioplegic solution to the heart during a cardiopulmonary bypass procedure by connecting an administration line to a cardioplegia cannula. Also known as a cardioplegia delivery set, it basically consists of tubing [e.g., polyvinyl chloride (PVC)] with connectors. It may have a single lumen or branched multiple-lumen design and include various types of connectors, clamps, and valves, depending on additional intended uses (e.g., venting, recirculation, and/or simultaneous perfusion of vein grafts). 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 false 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
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