Mui Scientific

GUDID 00678467505750

84-Channel Customized Reusable Colonic High Resolution Catheter

H & A Mui Enterprises Inc

Gastrointestinal manometric catheter, non-electronic Gastrointestinal manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic
Primary Device ID00678467505750
NIH Device Record Keye8e0149f-c616-4f10-8c7b-10fed9f0d175
Commercial Distribution StatusIn Commercial Distribution
Brand NameMui Scientific
Version Model NumberCR4-1136
Company DUNS243872611
Company NameH & A Mui Enterprises Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9058905525
Emailmail@muiscientific.com
Phone9058905525
Emailmail@muiscientific.com
Phone9058905525
Emailmail@muiscientific.com
Phone9058905525
Emailmail@muiscientific.com
Phone9058905525
Emailmail@muiscientific.com
Phone9058905525
Emailmail@muiscientific.com
Phone9058905525
Emailmail@muiscientific.com
Phone9058905525
Emailmail@muiscientific.com
Phone9058905525
Emailmail@muiscientific.com
Phone9058905525
Emailmail@muiscientific.com
Phone9058905525
Emailmail@muiscientific.com
Phone9058905525
Emailmail@muiscientific.com
Phone9058905525
Emailmail@muiscientific.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100678467505750 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FFXSystem, Gastrointestinal Motility (Electrical)
KLAMonitor, Esophageal Motility, And Tube

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-10-31
Device Publish Date2018-08-29

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