MuiScientific

GUDID 00678467005526

Non Latex Balloon(100ml) Pieces POLYISOPRENE

H & A Mui Enterprises Inc

Gastrointestinal manometric catheter, non-electronic
Primary Device ID00678467005526
NIH Device Record Keye06a1423-0ce8-4202-ab56-473cadc03d52
Commercial Distribution StatusIn Commercial Distribution
Brand NameMuiScientific
Version Model NumberCBE5P
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
GS100678467005526 [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 Date2019-11-22
Device Publish Date2019-06-24

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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