Mui Scientific

GUDID 00678467003065

Customized AR Barostat Balloon Replacement

H & A Mui Enterprises Inc

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 ID00678467003065
NIH Device Record Key3524d135-9c19-4621-9809-146abff72d18
Commercial Distribution StatusIn Commercial Distribution
Brand NameMui Scientific
Version Model NumberCT-BP1082
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
Emailmail@muiscientific.com
Phone(905)-890-5525
Emailmail@muiscientific.com
Phone(905)-890-5525
Emailmail@muiscientific.com
Phone(905)-890-5525
Emailmail@muiscientific.com
Phone(905)-890-5525
Emailmail@muiscientific.com
Phone(905)-890-5525
Emailmail@muiscientific.com
Phone(905)-890-5525
Emailmail@muiscientific.com
Phone(905)-890-5525
Emailmail@muiscientific.com
Phone(905)-890-5525
Emailmail@muiscientific.com
Phone(905)-890-5525
Emailmail@muiscientific.com
Phone(905)-890-5525
Emailmail@muiscientific.com
Phone(905)-890-5525
Emailmail@muiscientific.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100678467003065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FFXSystem, Gastrointestinal Motility (Electrical)
GBACatheter, Balloon Type

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-12-04
Device Publish Date2019-10-16

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