Muiscientific

GUDID 10678467507027

Customized Single-Use Esophageal Barostat Catheter

H & A Mui Enterprises Inc

Gastrointestinal manometric catheter, non-electronic
Primary Device ID10678467507027
NIH Device Record Keyb7e8b042-70fc-40dc-8afc-4af98d912b33
Commercial Distribution StatusIn Commercial Distribution
Brand NameMuiscientific
Version Model NumberS7-BE-1004
Company DUNS243872611
Company NameH & A Mui Enterprises Inc
Device Count10
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 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
GS100678467507020 [Unit of Use]
GS110678467507027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FFXSystem, Gastrointestinal Motility (Electrical)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-12-13
Device Publish Date2019-08-01

On-Brand Devices [Muiscientific]

00678467005526Non Latex Balloon(100ml) Pieces POLYISOPRENE
10678467507027Customized Single-Use Esophageal Barostat Catheter
00678467507037Customized Reusable Small Bowel 18ch Catheter

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