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Latitude Catheter

FDA UDI

Class II (US FDA UDI)

by Unisensor AG

Identity

Trade Name
Latitude Catheter FDA UDI
Generic Name
Gastrointestinal motility manometric catheter, non-electronic FDA UDI
Model / Reference
GIM6000D00 FDA UDI

Identifiers

Catalog Number
K194AC-L-1502 FDA UDI
Primary DI / UDI-DI
07640172972533 FDA UDI
FDA Product Code
KLA FDA UDI
GMDN Term
Gastrointestinal motility manometric catheter, non-electronic 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

Dimensions & Sizes

Size
Catheter Gauge — 19 French FDA UDI

Category: Gastrointestinal motility manometric catheter, non-electronic

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

Similar devices

Also classified as Gastrointestinal motility manometric catheter, non-electronic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Unisensor AG

Sources (1)

  • FDA UDI 1e05a1b3-7a52-4f95-abb1-12afbb5c37da 35 fields · synced Jun 8, 2026