Home GUDID 14858218671006 Test2 Release 1.6.3
Primary DI 14858218671006
Brand Test2 Release 1.6.3
Company Booz Allen Hamilton Inc.
Model Test2XML
Catalog number DRT
Device description Test2 Release 1.6.3 XML Validation
Published 2017-05-05
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx true
OTC true
Sterile false
Single use true Product Codes# Code, Name table Code Name JHX FLUOROMETRIC METHOD, CPK OR ISOENZYMES
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JHX Fluorometric Method, Cpk Or Isoenzymes Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 14858218671006 Primary GS1 0 89786756453423 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 14858218671006 14858218671006 89786756453423 89786756453423
GMDN Terms# Term, Definition table Term Definition Peripheral angioplasty balloon catheter, basic A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include microsurgical blades (atherotomes) to score the plaque. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Total Volume 200 Centiliter
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature -1.01 Degrees Fahrenheit 1.01 Degrees Fahrenheit
Sterilization Methods# Method table Method Dry Heat Sterilization
Regulatory Flags# DUNS number 053588527 Device count 50 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number true 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 true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 14858218671008 Test2 Release 1.6.3 Test2XML DRT 2017-05-05 14858218671009 Test2 Release 1.6.3 Test2XML DRT 2017-05-05
Other Devices Sharing Product Codes# 
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