Mui Scientific

GUDID 00678467507310

21-Channel Customized Reusable Esophageal Catheter

H & A Mui Enterprises Inc

Gastrointestinal manometric catheter, non-electronic
Primary Device ID00678467507310
NIH Device Record Key4d472277-b6c8-4ed2-8051-4c12ade4b5b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameMui Scientific
Version Model NumberCE4-1302
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

Phone(905)-890-5525
Email[email protected]

Device Identifiers

Device Issuing AgencyDevice ID
GS100678467507310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLAMonitor, Esophageal Motility, And Tube

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-25
Device Publish Date2020-03-17

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