High Pressure Luer Lock Set, Single Lumen 300mmHg

GUDID 20860936000345

THERMEDX, LLC

Hysteroscopic irrigation/insufflation system
Primary Device ID20860936000345
NIH Device Record Key1ff34655-34a0-4e50-b4cc-06148d5006c3
Commercial Distribution StatusIn Commercial Distribution
Brand NameHigh Pressure Luer Lock Set, Single Lumen 300mmHg
Version Model NumberHLL003
Company DUNS022465035
Company NameTHERMEDX, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Pressure400 millibar
Pressure400 millibar
Pressure400 millibar
Pressure400 millibar
Pressure400 millibar
Pressure400 millibar
Pressure400 millibar
Pressure400 millibar
Pressure400 millibar

Device Identifiers

Device Issuing AgencyDevice ID
GS100860936000341 [Primary]
GS120860936000345 [Package]
Contains: 00860936000341
Package: Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXArthroscope

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

Devices Manufactured by THERMEDX, LLC

00860936000310 - Fluid Management System2018-07-06
00860936000327 - Fluid Management System2018-07-06
20860936000338 - Luer Lock Set, Single Lumen2018-07-06
20860936000345 - High Pressure Luer Lock Set, Single Lumen 300mmHg2018-07-06
20860936000345 - High Pressure Luer Lock Set, Single Lumen 300mmHg2018-07-06
20860936000352 - Tubing Set - Single Lumen, Inflow with Dual Outflow2018-07-06
20860936000369 - Urology Set2018-07-06 Urology Set

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