Mui Sicentific

GUDID 00678467005403

Non-Latex Balloon (600ml) Pieces- POLYISOPRENE

H & A Mui Enterprises Inc

Gastrointestinal manometric catheter, non-electronic

• Primary Device ID: 00678467005403
• NIH Device Record Key: ba46149a-ea21-42f5-b4c7-2abbe64bd5a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mui Sicentific
• Version Model Number: CBL7P
• 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	00678467005403 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-22
• Device Publish Date: 2019-06-24

Devices Manufactured by H & A Mui Enterprises Inc

• 00678467508362 - Mui Scientific: 2025-09-23 Small Intestine Sphincter of ODDI 3 Channel Catheter
• 00678467508355 - Mui Scientific: 2025-09-05 Single Use Anorectal 24 Channel Catheter with balloon
• 00678467508348 - Mui Scientific: 2025-09-03 Single Use Anorectal 24 Channel Catheter
• 00678467508331 - Mui Scientific: 2025-08-29 Single Use Esophageal 24 Channel Catheter
• 00678467508324 - Mui Scientific: 2025-08-08 PatCom SD Distal Chip Endoscope
• 00678467508300 - Mui Scientific: 2025-07-30 Single Use Colonic 8 Channel Catheter
• 00678467508317 - Mui Scientific: 2025-07-30 Single Use Colonic 8 Channel Catheter
• 00678467508102 - Mui Scientific: 2025-07-11 Single Use Esophageal 24 Channel Catheter