Home GUDID H862TC600L0
Gravity Drainage Bag
Primary DI H862TC600L0
Brand Gravity Drainage Bag
Company URESIL, LLC
Model TC600L
Catalog number TC600L
Device description Optimus 600 Gravity Drainage Bag w/36" I.T.
Published 2017-09-11
Public version status Update
Distribution status Not 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 EXF Bag, Bile Collecting
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EXF Bag, Bile Collecting Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status H862TC600L1 Package HIBCC 10 Not in Commercial Distribution H862TC600L2 Package HIBCC 2 Not in Commercial Distribution H862TC600L0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Closed-wound/centesis drainage receptacle A sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent material being removed during drainage of a body cavity, a closed-wound, and/or the bile duct; it is not intended for drainage of cerebrospinal fluid (CSF) or blood. It is typically in the form of a bottle, bag, or bulb with fluid volume markers, and might include a hand-operated pump (e.g., suction bulb) and tubing; it does not include any invasive components or powered devices. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 0 Total Volume 0
Regulatory Flags# DUNS number 192559557 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 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published H862TFDR0 Tru-Fix Catheter Fixation Kit TFD-R TFD-R 2016-08-31 H862TFK060 Tru-Fix Catheter Fixation Kit TFK-06 TFK-06 2016-08-31 H862TFK080 Tru-Fix Catheter Fixation Kit TFK-08 TFK-08 2016-08-31 H862TFK100 Tru-Fix Catheter Fixation Kit TFK-10 TFK-10 2016-08-31 H862TFK120 Tru-Fix Catheter Fixation Kit TFK-12 TFK-12 2016-08-31 H862TFK140 Tru-Fix Catheter Fixation Kit TFK-14 TFK-14 2016-08-31 H862TFK160 Tru-Fix Catheter Fixation Kit TFK-16 TFK-16 2016-08-31 00817640020639 Tru-Fix Catheter Fixation Kit TFD-R TFD-R 2022-05-12 00817640020646 Tru-Fix Catheter Fixation Kit TFK-06 TFK-06 2022-05-12 00817640020653 Tru-Fix Catheter Fixation Kit TFK-08 TFK-08 2022-05-12 00817640020660 Tru-Fix Catheter Fixation Kit TFK-10 TFK-10 2022-05-12 00817640020677 Tru-Fix Catheter Fixation Kit TFK-12 TFK-12 2022-05-12 00817640020684 Tru-Fix Catheter Fixation Kit TFK-14 TFK-14 2022-05-12 00817640020691 Tru-Fix Catheter Fixation Kit TFK-16 TFK-16 2022-05-12 H862DFALL0 Aspiration and Flush Assembly DFA-LL DFA-LL 2016-08-29 H862TV11100 Thora-Vent Thoracic Vent TV11-10 TV11-10 2016-09-07 H862TV11130 Thora-Vent Thoracic Vent TV11-13 TV11-13 2016-09-07 H862TV13100 Thora-Vent Thoracic Vent TV13-10 TV13-10 2016-09-07 H862TV13130 Thora-Vent Thoracic Vent TV13-13 TV13-13 2016-09-07 H862UFALL0 Universal Funnel Adapter UFA-LL UFA-LL 2016-08-30
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