Mui Scienific

GUDID 00678467005427

Customized Reusable Colonic 8 Channel Catheter

H & A Mui Enterprises Inc

Gastrointestinal manometric catheter, non-electronic 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: 00678467005427
• NIH Device Record Key: f401d5ae-a303-4d37-9bb3-aff771c94ff5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mui Scienific
• Version Model Number: C7-R8-1083
• 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: 9058905525
• Email: mail@muiscientific.com
• Phone: 9058905525
• Email: mail@muiscientific.com
• Phone: 9058905525
• Email: mail@muiscientific.com
• Phone: 9058905525
• Email: mail@muiscientific.com
• Phone: 9058905525
• Email: mail@muiscientific.com
• Phone: 9058905525
• Email: mail@muiscientific.com
• Phone: 9058905525
• Email: mail@muiscientific.com
• Phone: 9058905525
• Email: mail@muiscientific.com
• Phone: 9058905525
• Email: mail@muiscientific.com
• Phone: 9058905525
• Email: mail@muiscientific.com
• Phone: 9058905525
• Email: mail@muiscientific.com
• Phone: 9058905525
• Email: mail@muiscientific.com
• Phone: 9058905525
• Email: mail@muiscientific.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00678467005427 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K823701

FDA Product Code

• FFX: System, Gastrointestinal Motility (Electrical)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-24
• Device Publish Date: 2018-07-24

On-Brand Devices [Mui Scienific]

• 00678467504678: 24-Ch Cust. Reusable Antro-Duodenal Catheter
• 00678467005700: Customized Reusable Anorectal 24 Channel Catheter (with Balloon)
• 00678467005427: Customized Reusable Colonic 8 Channel Catheter