| Primary Device ID | 00678467000545 |
| NIH Device Record Key | 72649c4c-3a62-41b2-859c-f1f0580be6b8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mui Scientific |
| Version Model Number | CB-CR-0001 |
| 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 | false |
| 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 |
| Phone | (905) 890-5525 |
| mail@muiscientific.com | |
| Phone | (905) 890-5525 |
| mail@muiscientific.com | |
| Phone | (905) 890-5525 |
| mail@muiscientific.com | |
| Phone | (905) 890-5525 |
| mail@muiscientific.com | |
| Phone | (905) 890-5525 |
| mail@muiscientific.com | |
| Phone | (905) 890-5525 |
| mail@muiscientific.com | |
| Phone | (905) 890-5525 |
| mail@muiscientific.com | |
| Phone | (905) 890-5525 |
| mail@muiscientific.com | |
| Phone | (905) 890-5525 |
| mail@muiscientific.com | |
| Phone | (905) 890-5525 |
| mail@muiscientific.com | |
| Phone | (905) 890-5525 |
| mail@muiscientific.com | |
| Phone | (905) 890-5525 |
| mail@muiscientific.com | |
| Phone | (905) 890-5525 |
| mail@muiscientific.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00678467000545 [Primary] |
| FFX | System, Gastrointestinal Motility (Electrical) |
| GBA | Catheter, Balloon Type |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-11-28 |
| Device Publish Date | 2016-09-23 |
| 00678467545008 | Customized Reusable Antroduodenal 8 Channel Catheter |
| 00678467539007 | Customized Reusable Anorectal 8 Channel Catheter |
| 00678467506665 | Customized Reusable Pediatric Esophageal 8 channel catheter |
| 00678467506658 | High Resolution Adult Pyloric Catheter |
| 00678467506634 | 22-Channel Customized Reusable Esophageal Catheter |
| 00678467506627 | Customized Single Use Pediatric Anorectal Barostat Catheter |
| 00678467506597 | Customized Single-Use Anorectal Barostat Catheter |
| 00678467506573 | Customized Reusable Anorectal 24-Ch Catheter |
| 00678467506566 | 24-Channel Customized Reusable Esophageal Catheter |
| 00678467506559 | 36CH CUSTOMIZED REUSABLE ANTRODUODENAL CATHETER |
| 00678467506542 | Customized single Use HRM Anorectal 24 Channel Catheter |
| 00678467506535 | customized single Use Anorectal 10 Channel catheter |
| 00678467506177 | Customized Single Use Esophageal Barostat Catheter |
| 00678467506139 | Customized Single Use Anorectal 1 Channel Catheter |
| 00678467506092 | Customized Single Use Pediatric Esophageal 2 Channel Catheter |
| 00678467506078 | Single Use Anorectal Balloon Expulsion Catheter (1 piece) |
| 00678467506061 | Customized Single Use Single Lumen Anorectal Catheter |
| 00678467506054 | Customized Single Use Single Lumen Anorectal Catheter |
| 00678467505996 | 24 CH CUSTOMIZED REUSABLE ESOPHAGEAL CATHETER |
| 00678467505965 | Cust. RU Nasoileal Aspiration Catheter |
| 00678467505941 | 41-Channel Customized Reusable Esophageal Catheter |
| 00678467505934 | 7CH CUSTOMIZED REUSABLE ANORECTAL CATHETER |
| 00678467505927 | 22 CH CUSTOMIZED REUSABLE ANTRO-DUODENAL CATHETER |
| 00678467505910 | 8-Channel Customized Reusable Pediatric Esophageal Catheter |
| 00678467505903 | 24 CH CUSTOMIZED REUSABLE ESOPHAGEAL CATHETER |
| 00678467505798 | 8-Channel Customized Reusable Esophageal Catheter |
| 00678467505767 | 22CH CUSTOMIZED REUSABLE ESOPHAGEAL CATHETER |
| 00678467505750 | 84-Channel Customized Reusable Colonic High Resolution Catheter |
| 10678467505719 | Customized Single-Use Anorectal Barostat Catheter |
| 00678467505507 | 35Ch Customized Reusable Esophageal Catheter |
| 00678467505446 | 16Ch Customized Reusable Pediatric Esophageal Catheter |
| 00678467505408 | 8Ch Customized Reusable Anorectal Catheter |
| 00678467505286 | Customized Single-Use Barostat Motility Catheter |
| 00678467505279 | 84Ch Customized Reusable Adult Colonic Catheter (30 cm transverse colon) |
| 00678467505262 | 40Ch Customized Reusable Colonic Catheter |
| 00678467505255 | 22Ch Customized Reusable Esophageal Catheter |
| 00678467505248 | 16Ch Cust. Reusable Esophageal Catheter |
| 00678467505231 | 22Ch Customized Reusable Esophageal Catheter |
| 00678467505125 | 5Ch Customized Reusable Esophageal Catheter |
| 00678467505118 | Rapid Barostat Bag Pump |
| 00678467505101 | 21Ch Cust. Reusable Small Bowel Catheter |
| 00678467505095 | 36Ch Cust. Reusable Esophageal Catheter |
| 00678467505064 | 41-Ch Cust. Reusable Esophageal Catheter |
| 00678467505057 | 32CH CUST. REUSABLE SMALL BOWEL CATHETER |
| 00678467505026 | 3Ch Customized Reusable Esophageal Sleeve Catheter |
| 00678467505002 | 8Ch Cust. Reusable Esophageal Sleeve Catheter |
| 00678467504999 | 20Ch Cust. Reusable Pediatric Esophageal Catheter |
| 00678467504968 | 21Ch CUST. REUSABLE SMALL BOWEL(ADM) CATHETER |
| 00678467504951 | 20Ch Customized Reusable Colonic Catheter |
| 00678467504913 | 8CH CUSTOMIZED REUSABLE ANORECTAL CATHETER |