Quick Pressure Monitor Set (Japan)

GUDID 00850007350024

Quick Pressure Monitor set (6/pk Chamber and side ported needle)

C2DX, INC.

Compartmental-pressure monitoring system, single-use
Primary Device ID00850007350024
NIH Device Record Key03fb42b8-2c40-4acb-ac9f-2965ea7c2420
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuick Pressure Monitor Set (Japan)
Version Model Number0295-002-000J
Company DUNS116981210
Company NameC2DX, INC.
Device Count6
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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

Customer Support Contacts

Phone888-902-2239
Emailc2dx@c2dxinc.com
Phone888-902-2239
Emailc2dx@c2dxinc.com
Phone888-902-2239
Emailc2dx@c2dxinc.com
Phone888-902-2239
Emailc2dx@c2dxinc.com
Phone888-902-2239
Emailc2dx@c2dxinc.com
Phone888-902-2239
Emailc2dx@c2dxinc.com
Phone888-902-2239
Emailc2dx@c2dxinc.com
Phone888-902-2239
Emailc2dx@c2dxinc.com
Phone888-902-2239
Emailc2dx@c2dxinc.com
Phone888-902-2239
Emailc2dx@c2dxinc.com
Phone888-902-2239
Emailc2dx@c2dxinc.com
Phone888-902-2239
Emailc2dx@c2dxinc.com
Phone888-902-2239
Emailc2dx@c2dxinc.com
Phone888-902-2239
Emailc2dx@c2dxinc.com
Phone888-902-2239
Emailc2dx@c2dxinc.com
Phone888-902-2239
Emailc2dx@c2dxinc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850007350024 [Unit of Use]
GS110850007350021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXCMonitor, Pressure, Intracompartmental

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-16
Device Publish Date2020-04-08

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