Mui Scientific

GUDID 00678467005212

Replacement Non-Latex Balloons - 100mL (5 pack) Polyisoprene

H & A Mui Enterprises Inc

Gastrointestinal manometric catheter, non-electronic
Primary Device ID00678467005212
NIH Device Record Key341cf253-d7ae-48c8-bb67-c6b6e9f53cf1
Commercial Distribution StatusIn Commercial Distribution
Brand NameMui Scientific
Version Model NumberBE5P(05)
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100678467000781 [Unit of Use]
GS100678467005212 [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 Number4
Public Version Date2019-11-22
Device Publish Date2016-09-23

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