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Epsimed

FDA UDI

Class II (US FDA UDI)

by Epsimed Llc

Identity

Trade Name
EPSIMED FDA UDI
Generic Name
General-purpose multi-parameter bedside monitor FDA UDI
Device Name
EPSIMED MN-100 Patient Monitor SN: J4700SG00067 FDA UDI
Model / Reference
MN-100 FDA UDI
Description
EPSIMED MN-100 Patient Monitor SN: J4700SG00067 FDA UDI

Identifiers

Primary DI / UDI-DI
06941900604292 FDA UDI
510(k) Number
K192343 FDA UDI
FDA Product Code
DXN FDA UDI
DQA FDA UDI
CCK FDA UDI
FLL FDA UDI
MWI 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
868.1400 FDA UDI
880.2910 FDA UDI
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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: General-purpose multi-parameter bedside monitor

Epsimed by Epsimed Llc — 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

K192343 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Epsimed Llc

Sources (1)

  • FDA UDI 4e364814-fa1f-4304-94bb-30a064ddc26c 34 fields · synced Jun 6, 2026