Identity
- Trade Name
- Distender II Barostat FDA UDI
- Generic Name
- Gastrointestinal barostat FDA UDI
- Device Name
- External Reservoir Unit 120 mL FDA UDI
- Model / Reference
- ERU-120 FDA UDI
- Description
- External Reservoir Unit 120 mL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00627843670902 FDA UDI
- 510(k) Number
- K991288 FDA UDI
- FDA Product Code
- FFX FDA UDI
- GMDN Term
- Gastrointestinal barostat FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1725 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Gastrointestinal barostat
Distender II Barostat by G & J Electronics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastrointestinal barostat.
- EndoFLIP — Covidien LP · Class II
- Mui Scientific — H & A Mui Enterprises Inc · Class II
- Mui Scientific — H & A Mui Enterprises Inc · Class II
- EndoFLIP Loaner Unit — Covidien LP · Class II
- Mui Scientific — H & A Mui Enterprises Inc · Class II
- EndoFLIP — Covidien LP · Class II
- EndoFLIP — Crospon, Ltd. · Class II
- Mui Scientific — H & A Mui Enterprises Inc · Class II
Cleared under the same submission
K991288 also covers:
- Distender II Barostat — G & J Electronics, Inc.
- Distender II Barostat — G & J Electronics, Inc.
- Distender II Barostat — G & J Electronics, Inc.
- Distender II Barostat — G & J Electronics, Inc.
- Distender II Barostat — G & J Electronics, Inc.
- Distender II Barostat — G & J Electronics, Inc.
- Distender II Barostat — G & J Electronics, Inc.
- Distender II Barostat — G & J Electronics, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- G & J Electronics, Inc.
Sources (1)
- FDA UDI 066aa4d4-569a-4fc2-8e20-5f788d1cca13 34 fields · synced Jun 6, 2026