FDA UDI
In Commercial Distribution
🇺🇸 United States
Mui Scientific
DI: 00678467505286
·
Model: S7-BR-1015X
·
H & A Mui Enterprises Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Mui Scientific
- Primary DI
- 00678467505286
- Version / Model
- S7-BR-1015X
- Company Name
- H & A Mui Enterprises Inc
- Labeler DUNS
- 243872611
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-24
- Public Version
- 3
- Public Version Date
- 2022-08-05
- Public Version Status
- Update
- Public Device Record Key
- 8ff98888-cecd-4421-bcf1-0917195d9dfa
Device Description
Customized Single-Use Barostat Motility Catheter
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FFX | System, Gastrointestinal Motility (Electrical) | Gastroenterology, Urology | 876.1725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17745 | Gastrointestinal motility manometric catheter, non-electronic | A non-electrical flexible tube intended to be inserted through the nose or rectum into the gastrointestinal (GI) tract for measuring pressure to assess peristaltic motility in the GI tract (e.g., oesophagus, stomach) or rectal musculature and anal sphincter functions, typically in the evaluation of GI disorders [e.g., gastro-oesophageal reflux disease (GERD), faecal incontinence]. It functions via infusion of water (water-perfused catheter) or insufflation of air/gas (air-charged catheter) into the catheter, whereby pressure signals are conducted to proximally-connected external pressure transducers in/connected to a dedicated analysis system. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00678467505286 | GS1 | ||||
| Package | 10678467505283 | GS1 | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 9058905525
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K973844 | 000 |