| Primary Device ID | 10678467505740 | 
| NIH Device Record Key | c85719a4-9586-44ee-b2a2-e0f59779a5e9 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Mui Scientific | 
| Version Model Number | S7-BPG-1008 | 
| Company DUNS | 243872611 | 
| Company Name | H & A Mui Enterprises Inc | 
| Device Count | 10 | 
| 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 | true | 
| 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 | 
| 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 | 00678467505743 [Unit of Use] | 
| GS1 | 10678467505740 [Primary] | 
| FFX | System, Gastrointestinal Motility (Electrical) | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2019-12-20 | 
| Device Publish Date | 2019-12-12 | 
| 00678467004819 | Customized Reusable Anorectal Barostat Catheter for rat | 
| 00678467004604 | Reusable Rectal Barostat Catheter for rat | 
| 00678467004598 | Customized Colon Barostat Catheter with Motility Channel | 
| 00678467004321 | Customized Barostat Catheter (3 Lumen) | 
| 00678467004215 | Anorectal Barostat Balloon 300mL | 
| 00678467004055 | Barostat Balloon Pillow-type (15mL) | 
| 00678467003836 | Customized Colon Barostat Catheter with Motility Channels | 
| 00678467003812 | AR Barostat Catheter Balloon (3cm tied L) | 
| 00678467003607 | Customized Rectal Barostat Catheter for mouse | 
| 00678467003591 | Customized Barostat Catheter for mouse | 
| 00678467003553 | Customized Rectal Barostat Catheter | 
| 00678467003546 | Customized Colon Barostat Catheter with Motility Channels | 
| 00678467003317 | Barostat Anorectal Balloon Replacement Pillow-type 400mL | 
| 00678467003263 | Customized Reusable Barostat Catheter with Motility | 
| 00678467003157 | Customized Barostat Anorectal Balloon Replacement | 
| 00678467003140 | Customized Reusable Barostat Catheter for rat | 
| 00678467003133 | Customized Barostat Balloon Replacement | 
| 00678467003065 | Customized AR Barostat Balloon Replacement | 
| 00678467003058 | Customized Reusable Anorectal Barostat | 
| 00678467002655 | Customized Reusable Anorectal Barostat | 
| 00678467002600 | Customized Reusable Gastric Barostat | 
| 00678467002549 | Customized Reusable Anorectal Barostat | 
| 00678467002426 | Customized Reusable Anorectal Barostat | 
| 00678467002358 | Customized Reusable Anorectal Barostat | 
| 00678467002150 | Customized Reusable Colonic Barostat with Motility Channels | 
| 00678467001924 | Customized Reusable Gastric Barostat (3 Lumen) | 
| 00678467001894 | Customized Barostat Balloon Replacement Anorectal Pillow-type 40mL | 
| 00678467001627 | Balloon Replacement Barostat Anorectal Pillow-type 500 mL | 
| 00678467506610 | Customized Barostat Balloon Pillow-type 500mL | 
| 00678467506337 | Customized Reusable Colonic Barostat Catheter | 
| 00678467506276 | Customized Reusable Colonic Barostat Catheter with Motility Channel | 
| 00678467506252 | Customized Barostat Balloon Pillow-type 30mL | 
| 00678467506184 | Customized Barostat Balloon Pillow-type 20mL | 
| 00678467006868 | Customized Reusable Extension Barostat Tubing | 
| 00678467006707 | Customized Barostat Balloon Pillow-type 20mL | 
| 00678467006677 | Customized Rectal Barostat Balloon Pillow-type 100 mL | 
| 00678467006547 | Customized Barostat Balloon Pillow-type 60mL | 
| 00678467006134 | Customized Reusable Gastric Barostat Catheter with Balloon | 
| 00678467005915 | Customized Barostat Balloon Pillow-type 15mL | 
| 00678467005847 | Customized Reusable Esophageal Barostat Catheter with 2 Motility Channels (for MRI) | 
| 00678467005007 | Customized Barostat Balloon | 
| 00678467004963 | Customized Reusable Gastric Barostat Catheter (3 Lumen) | 
| 10678467504378 | Customized Single-Use Anorectal Barostat Catheter | 
| 10678467504361 | Customized Single-Use Anorectal Barostat Catheter | 
| 10678467504347 | Customized Single-Use Anorectal Barostat Catheter | 
| 10678467505740 | Customized Single-Use Pediatric Gastric Barostat Catheter | 
| 10678467505733 | Customized Single-Use Pediatric Gastric Barostat Catheter | 
| 10678467505726 | Customized Single-Use Anorectal Barostat Catheter | 
| 10678467505702 | Customized Single-Use Anorectal Barostat Catheter | 
| 10678467505078 | Customized Single-Use Barostat Motility Catheter |