Fujifilm

FDA UDI

Class II (US FDA UDI)

by FUJIFILM Corporation

Identity

Trade Name: FUJIFILM FDA UDI
Generic Name: Tissue saturation oximeter FDA UDI
Device Name: The Image Processing Unit EX-0 is an optional module intended for use as an adjunctive monitor of the hemoglobin oxygen saturation of blood in superficial tissue of the endoscopic observation image area in patients at risk for ischemic states. This product may be used on all patients requiring endoscopic examination when using a Fujinon/FUJIFILM medical endoscope, video processor and light source together with monitor, recorder and various peripheral devices. The prospective clinical value of measurements made with OXEI has not been demonstrated in disease states. FDA UDI
Model / Reference: EX-0 FDA UDI
Description: The Image Processing Unit EX-0 is an optional module intended for use as an adjunctive monitor of the hemoglobin oxygen saturation of blood in superficial tissue of the endoscopic observation image area in patients at risk for ischemic states. This product may be used on all patients requiring endoscopic examination when using a Fujinon/FUJIFILM medical endoscope, video processor and light source together with monitor, recorder and various peripheral devices. The prospective clinical value of measurements made with OXEI has not been demonstrated in disease states. FDA UDI

Identifiers

Primary DI / UDI-DI: 04547410446104 FDA UDI
FDA Product Code: NTN FDA UDI
FET FDA UDI
GCJ FDA UDI
MUD FDA UDI
NWB FDA UDI
PEA FDA UDI
GMDN Term: Tissue saturation oximeter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
870.2700 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Tissue saturation oximeter

Fujifilm by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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

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Manufacturer

Manufacturer: FUJIFILM Corporation

Sources (1)

FDA UDI 82921b14-94c1-4fa3-a126-2d6ad7fa7158 34 fields · synced May 31, 2026