MuiScientific

GUDID 00678467005526

Non Latex Balloon(100ml) Pieces POLYISOPRENE

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: 00678467005526
• NIH Device Record Key: e06a1423-0ce8-4202-ab56-473cadc03d52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MuiScientific
• Version Model Number: CBE5P
• 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	00678467005526 [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: 2
• Public Version Date: 2019-11-22
• Device Publish Date: 2019-06-24

On-Brand Devices [MuiScientific]

• 00678467005526: Non Latex Balloon(100ml) Pieces POLYISOPRENE
• 10678467507027: Customized Single-Use Esophageal Barostat Catheter
• 00678467507037: Customized Reusable Small Bowel 18ch Catheter