Identity
- Trade Name
- pHTip Disposable Catheter FDA UDI
- Generic Name
- Gastro-oesophageal pH/impedance catheter, non-sterile FDA UDI
- Model / Reference
- K6011-I-0731 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640172972519 FDA UDI
- FDA Product Code
- FFX FDA UDI
- GMDN Term
- Gastro-oesophageal pH/impedance catheter, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1725 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 6 French FDA UDI
pHTip Disposable Catheter by Unisensor AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Unisensor AG
Sources (1)
- FDA UDI 57cfa17e-ee39-47ec-8bd5-0edf634237f5 35 fields · synced Jun 8, 2026