| Primary Device ID | 00678467002549 |
| NIH Device Record Key | df905740-2746-40c4-812a-c9985f99b9cf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mui Scientific |
| Version Model Number | C7-CB-1078 |
| 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 |
| 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 | 00678467002549 [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 | 2 |
| Public Version Date | 2019-12-04 |
| Device Publish Date | 2019-10-16 |
| 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 |