POCone Infrared Spectrophotometer

FDA UDI

Class I (US FDA UDI)

by Otsuka Electronics

Identity

Trade Name: POCone Infrared Spectrophotometer FDA UDI
Generic Name: Infrared spectrometry breath analyser IVD FDA UDI
Device Name: The POCone Infrared Spectrophotometer is an in vitro diagnostic device designed to measure changes in 13CO2 content in breath CO2 gas by infrared spectroscopic analysis. The POCone Infrared Spectrophotometer is intended for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacterpylori (H. pylon) infection. The POCone Infrared Spectrophotometer is suitable for use in both point of care and clinical laboratory settings. FDA UDI
Model / Reference: POCone FDA UDI
Description: The POCone Infrared Spectrophotometer is an in vitro diagnostic device designed to measure changes in 13CO2 content in breath CO2 gas by infrared spectroscopic analysis. The POCone Infrared Spectrophotometer is intended for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacterpylori (H. pylon) infection. The POCone Infrared Spectrophotometer is suitable for use in both point of care and clinical laboratory settings. FDA UDI

Identifiers

Primary DI / UDI-DI: 04987035343417 FDA UDI
510(k) Number: K041148 FDA UDI
FDA Product Code: JJQ FDA UDI
GMDN Term: Infrared spectrometry breath analyser IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2300 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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Implantable

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Contains Latex

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Prescription Use

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Over-the-Counter

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Convenience Kit

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Combination Product

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HCT/P

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Premarket Exempt

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Lot / Batch Number

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Serial Number

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Expiration Date

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Manufacturing Date

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Category: Infrared spectrometry breath analyser IVD

POCone Infrared Spectrophotometer by Otsuka Electronics — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Otsuka Electronics

Sources (1)

FDA UDI e70075ce-a2d5-4d3e-a4f3-229a090f0d84 35 fields · synced May 30, 2026