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pHTip Disposable Catheter

FDA UDI

Class II (US FDA UDI)

by Unisensor AG

Identity

Trade Name
pHTip Disposable Catheter FDA UDI
Generic Name
Gastro-oesophageal pH/impedance catheter, non-sterile FDA UDI
Model / Reference
K6011-EI-0632 FDA UDI

Identifiers

Primary DI / UDI-DI
07640172972434 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
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
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 6 French FDA UDI

Category: Gastro-oesophageal pH/impedance catheter, non-sterile

pHTip Disposable Catheter by Unisensor AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gastro-oesophageal pH/impedance catheter, non-sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Unisensor AG

Sources (1)

  • FDA UDI 92572a3e-ae35-48e1-9f61-1f3170ab014a 34 fields · synced May 30, 2026