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TM-Oxi System

FDA UDI

Class II (US FDA UDI)

by Ld Technology Llc

Identity

Trade Name
TM-Oxi System FDA UDI
Generic Name
Manual-inflation electronic sphygmomanometer, non-portable FDA UDI
Device Name
"Oxi-W system is intended for use: To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To analyze the pulse waveform (Photoplethysmography or PTG) provided by the oximeter. It only provides mathematical analysis of the input of the PTG using the first and second derivatives of the PTG values related to the microvascular condition. To analyze the basic rhythms of the NN or RR intervals in heart rate from the PTG, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analysis of the heart rate variability values related to the autonomic nervous system function." FDA UDI
Model / Reference
B001 FDA UDI
Description
"Oxi-W system is intended for use: To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To analyze the pulse waveform (Photoplethysmography or PTG) provided by the oximeter. It only provides mathematical analysis of the input of the PTG using the first and second derivatives of the PTG values related to the microvascular condition. To analyze the basic rhythms of the NN or RR intervals in heart rate from the PTG, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analysis of the heart rate variability values related to the autonomic nervous system function." FDA UDI

Identifiers

Primary DI / UDI-DI
B322B0011 FDA UDI
FDA Product Code
MWI FDA UDI
GMDN Term
Manual-inflation electronic sphygmomanometer, non-portable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Manual-inflation electronic sphygmomanometer, non-portable

TM-Oxi System by Ld Technology Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Manual-inflation electronic sphygmomanometer, non-portable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ld Technology Llc

Sources (1)

  • FDA UDI c3d26ae8-c4a8-4028-9a53-5660e13d790c 34 fields · synced Jun 8, 2026