FDA UDI
In Commercial Distribution
🇺🇸 United States
Distender II Barostat
DI: 00627843670902
·
Model: ERU-120
·
G&J Electronics Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Distender II Barostat
- Primary DI
- 00627843670902
- Version / Model
- ERU-120
- Company Name
- G&J Electronics Inc
- Labeler DUNS
- 203222252
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-14
- Public Version
- 4
- Public Version Date
- 2020-07-23
- Public Version Status
- Update
- Public Device Record Key
- 066aa4d4-569a-4fc2-8e20-5f788d1cca13
Device Description
External Reservoir Unit 120 mL
Device Characteristics
- Single Use
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| 45569 | Gastrointestinal barostat | A computerized pneumatic device designed to measure tension-sensory threshold and motility in the gastrointestinal tract during neurogastroenterology assessment. It maintains a preselected pressure in an intragastric bag (balloon) of a dedicated catheter that is inserted into the gastrointestinal tract (e.g., oesophagus, stomach, intestines, rectum) and registers the pressure changes of the air pumped into the balloon at a predetermined speed (internal pressure data), and simultaneously measures the volume of air that has been used. The collected data can be used in the diagnosis of gastrointestinal disorders such as dysphagia, nausea, vomiting, anorexia, bulimia, or constipation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00627843670902 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K991288 | 000 |