Mui Scientific

GUDID 10678467000740

Single-Use Barostat Catheter (rectal for MRI)

H & A Mui Enterprises Inc

Gastrointestinal manometric catheter, non-electronic
Primary Device ID10678467000740
NIH Device Record Key13802732-1379-47ad-8126-cfc9aff7007b
Commercial Distribution StatusIn Commercial Distribution
Brand NameMui Scientific
Version Model NumberS7-CB-R001
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 Usetrue
Lot Batchtrue
Serial Numberfalse
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
Phone(905) 890-5525
Emailmail@muiscientific.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100678467000743 [Primary]
GS110678467000740 [Package]
Contains: 00678467000743
Package: Box [10 Units]
In Commercial Distribution

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 Number5
Public Version Date2019-12-12
Device Publish Date2016-09-23

On-Brand Devices [Mui Scientific]

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00678467539007Customized Reusable Anorectal 8 Channel Catheter
00678467506665Customized Reusable Pediatric Esophageal 8 channel catheter
00678467506658High Resolution Adult Pyloric Catheter
0067846750663422-Channel Customized Reusable Esophageal Catheter
00678467506627Customized Single Use Pediatric Anorectal Barostat Catheter
00678467506597Customized Single-Use Anorectal Barostat Catheter
00678467506573Customized Reusable Anorectal 24-Ch Catheter
0067846750656624-Channel Customized Reusable Esophageal Catheter
0067846750655936CH CUSTOMIZED REUSABLE ANTRODUODENAL CATHETER
00678467506542Customized single Use HRM Anorectal 24 Channel Catheter
00678467506535customized single Use Anorectal 10 Channel catheter
00678467506177Customized Single Use Esophageal Barostat Catheter
00678467506139Customized Single Use Anorectal 1 Channel Catheter
00678467506092Customized Single Use Pediatric Esophageal 2 Channel Catheter
00678467506078Single Use Anorectal Balloon Expulsion Catheter (1 piece)
00678467506061Customized Single Use Single Lumen Anorectal Catheter
00678467506054Customized Single Use Single Lumen Anorectal Catheter
0067846750599624 CH CUSTOMIZED REUSABLE ESOPHAGEAL CATHETER
00678467505965Cust. RU Nasoileal Aspiration Catheter
0067846750594141-Channel Customized Reusable Esophageal Catheter
006784675059347CH CUSTOMIZED REUSABLE ANORECTAL CATHETER
0067846750592722 CH CUSTOMIZED REUSABLE ANTRO-DUODENAL CATHETER
006784675059108-Channel Customized Reusable Pediatric Esophageal Catheter
0067846750590324 CH CUSTOMIZED REUSABLE ESOPHAGEAL CATHETER
006784675057988-Channel Customized Reusable Esophageal Catheter
0067846750576722CH CUSTOMIZED REUSABLE ESOPHAGEAL CATHETER
0067846750575084-Channel Customized Reusable Colonic High Resolution Catheter
10678467505719Customized Single-Use Anorectal Barostat Catheter
0067846750550735Ch Customized Reusable Esophageal Catheter
0067846750544616Ch Customized Reusable Pediatric Esophageal Catheter
006784675054088Ch Customized Reusable Anorectal Catheter
00678467505286Customized Single-Use Barostat Motility Catheter
0067846750527984Ch Customized Reusable Adult Colonic Catheter (30 cm transverse colon)
0067846750526240Ch Customized Reusable Colonic Catheter
0067846750525522Ch Customized Reusable Esophageal Catheter
0067846750524816Ch Cust. Reusable Esophageal Catheter
0067846750523122Ch Customized Reusable Esophageal Catheter
006784675051255Ch Customized Reusable Esophageal Catheter
00678467505118Rapid Barostat Bag Pump
0067846750510121Ch Cust. Reusable Small Bowel Catheter
0067846750509536Ch Cust. Reusable Esophageal Catheter
0067846750506441-Ch Cust. Reusable Esophageal Catheter
0067846750505732CH CUST. REUSABLE SMALL BOWEL CATHETER
006784675050263Ch Customized Reusable Esophageal Sleeve Catheter
006784675050028Ch Cust. Reusable Esophageal Sleeve Catheter
0067846750499920Ch Cust. Reusable Pediatric Esophageal Catheter
0067846750496821Ch CUST. REUSABLE SMALL BOWEL(ADM) CATHETER
0067846750495120Ch Customized Reusable Colonic Catheter
006784675049138CH CUSTOMIZED REUSABLE ANORECTAL CATHETER

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