Home GUDID H965640000901 NAMIC
Primary DI H965640000901
Brand NAMIC
Company NAVILYST MEDICAL, INC.
Model 64000090
Device description CONTRAST CONTROLLER
Published 2016-09-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name IZI System, x-ray, angiographic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class IZI System, X-Ray, Angiographic Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status H965640000901 Package HIBCC 25 In Commercial Distribution H965640000900 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Intravenous administration set A collection of noninvasive devices designed to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, clamps; the bag/bottle may be included. It does not include devices intended for invasive use nor a heat exchanger. This is a single-use device.
Regulatory Flags# DUNS number 809699023 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00841962120548 Alpine Stirrups, Metric, Left Qfix IZI 2026-04-14 00841962120555 Alpine Stirrups, Metric, Right Qfix IZI 2026-04-14 00841962120388 Lumen AirShuttle Qfix IZI 2025-12-02 08600105136202 RE3 Digital Surgery Systems, Inc. IZI 2025-07-15 10193489068184 NAMIC MEDLINE INDUSTRIES, INC. IZI 2023-12-21 10193489068191 NAMIC MEDLINE INDUSTRIES, INC. IZI 2023-12-21 10193489068207 NAMIC MEDLINE INDUSTRIES, INC. IZI 2023-12-21 00195278719263 Allia GE MEDICAL SYSTEMS IZI 2023-12-08 00195278719577 Allia GE MEDICAL SYSTEMS IZI 2023-12-08 00195278719720 Allia GE MEDICAL SYSTEMS IZI 2023-12-08 00195278719744 Allia GE MEDICAL SYSTEMS IZI 2023-12-08 10193489068092 MEDLINE MEDLINE INDUSTRIES, INC. IZI 2023-09-15 10193489140170 MEDLINE MEDLINE INDUSTRIES, INC. IZI 2023-09-15 10841962118733 Iris AirShuttle™ Qfix IZI 2023-04-10 00195278485144 Allia GE MEDICAL SYSTEMS IZI 2022-04-13 00195278485168 Allia GE MEDICAL SYSTEMS IZI 2022-04-08 00860001790290 Sterimed STERIMED LLC IZI 2021-09-29 00860007655609 Sterimed STERIMED LLC IZI 2021-09-29 10193489058826 NAMIC MEDLINE INDUSTRIES, INC. IZI 2021-07-26 10193489058833 NAMIC MEDLINE INDUSTRIES, INC. IZI 2021-07-26 10193489059038 NAMIC MEDLINE INDUSTRIES, INC. IZI 2021-07-26 10193489059458 NAMIC MEDLINE INDUSTRIES, INC. IZI 2021-07-26 20193489066927 NAMIC MEDLINE INDUSTRIES, INC. IZI 2021-05-12 00195278215543 Allia GE MEDICAL SYSTEMS IZI 2021-03-31 00195278215550 Allia GE MEDICAL SYSTEMS IZI 2021-03-31 10858701006213 SPY Novadaq Technologies Inc IZI 2020-09-21 00860001790214 Sterimed STERIMED LLC IZI 2020-04-27 00810116023011 Dornier MedTech DORNIER MEDTECH AMERICA, INC. IZI 2020-03-17 00810116023028 Dornier MedTech DORNIER MEDTECH AMERICA, INC. IZI 2020-03-17 00840682147378 INNOVA GE MEDICAL SYSTEMS IZI 2020-02-03
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