Mui Scinetific

GUDID 00678467506801

Customized Reusable small Bowel Catheter

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 ID	00678467506801
NIH Device Record Key	c53ac05f-6664-46f8-8656-4afaa08bab96
Commercial Distribution Status	In Commercial Distribution
Brand Name	Mui Scinetific
Version Model Number	CE4-1286
Company DUNS	243872611
Company Name	H & A Mui Enterprises Inc
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Customer Support Contacts

Phone	(905)-890-5525
Email	mail@muiscientific.com
Phone	(905)-890-5525
Email	mail@muiscientific.com
Phone	(905)-890-5525
Email	mail@muiscientific.com
Phone	(905)-890-5525
Email	mail@muiscientific.com
Phone	(905)-890-5525
Email	mail@muiscientific.com
Phone	(905)-890-5525
Email	mail@muiscientific.com
Phone	(905)-890-5525
Email	mail@muiscientific.com
Phone	(905)-890-5525
Email	mail@muiscientific.com
Phone	(905)-890-5525
Email	mail@muiscientific.com
Phone	(905)-890-5525
Email	mail@muiscientific.com
Phone	(905)-890-5525
Email	mail@muiscientific.com
Phone	(905)-890-5525
Email	mail@muiscientific.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00678467506801 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K983665

FDA Product Code

FFX	System, Gastrointestinal Motility (Electrical)
KLA	Monitor, Esophageal Motility, And Tube

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2019-10-31
Device Publish Date	2019-04-12

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