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Direct Supply

FDA UDI

Class II (US FDA UDI)

by Mediana.CO.LTD

Identity

Trade Name
Direct Supply FDA UDI
Generic Name
General-purpose multi-parameter bedside monitor FDA UDI
Device Name
The V20, V20a, AVSM3 SNF are intended to be used to monitor noninvasive blood pressure(NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation(SpO2), pulse rate (PR) and temperature (TEMP) in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The V20 and V20a are for adult, pediatric and neonatal patients and the AVSM3 SNF is for adult patients only. Also, the V20 is only suitable for single measurement but V20a and AVSM3 SNF are suitable for single as well as continuous measurement. FDA UDI
Model / Reference
AVSM3 FDA UDI
Description
The V20, V20a, AVSM3 SNF are intended to be used to monitor noninvasive blood pressure(NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation(SpO2), pulse rate (PR) and temperature (TEMP) in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The V20 and V20a are for adult, pediatric and neonatal patients and the AVSM3 SNF is for adult patients only. Also, the V20 is only suitable for single measurement but V20a and AVSM3 SNF are suitable for single as well as continuous measurement. FDA UDI

Identifiers

Catalog Number
AVSM3SNF-3XBNDU FDA UDI
Primary DI / UDI-DI
18800003465535 FDA UDI
510(k) Number
K200434 FDA UDI
FDA Product Code
DXN FDA UDI
DQA FDA UDI
FLL FDA UDI
GMDN Term
General-purpose multi-parameter bedside monitor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1130 FDA UDI
870.2700 FDA UDI
880.2910 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: General-purpose multi-parameter bedside monitor

Direct Supply by Mediana.CO.LTD — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose multi-parameter bedside monitor.

Cleared under the same submission

K200434 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mediana.CO.LTD

Sources (1)

  • FDA UDI ef78c0a2-d6ad-42ef-bff7-eb8e580dffb2 35 fields · synced Jun 8, 2026