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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 AVSM2 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients 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 AVSM2 is suitable for continuous operation. FDA UDI
Model / Reference
AVSM2 FDA UDI
Description
The AVSM2 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients 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 AVSM2 is suitable for continuous operation. FDA UDI

Identifiers

Catalog Number
V10D-3PBCRU FDA UDI
Primary DI / UDI-DI
18800003439420 FDA UDI
510(k) Number
K170497 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
Not 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

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

Cleared under the same submission

K170497 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 67ccf278-3e9a-47e6-bf3c-da28c64a9670 36 fields · synced Jun 8, 2026