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Vital Signs Monitor

FDA UDI

Class II (US FDA UDI)

by Edan Instruments, Inc.

Identity

Trade Name
Vital Signs Monitor FDA UDI
Generic Name
General-purpose multi-parameter bedside monitor FDA UDI
Model / Reference
M3A FDA UDI

Identifiers

Primary DI / UDI-DI
06944413800786 FDA UDI
510(k) Number
K131818 FDA UDI
FDA Product Code
DQA FDA UDI
FLL FDA UDI
DXN FDA UDI
GMDN Term
General-purpose multi-parameter bedside monitor FDA UDI

Classification

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

Category: General-purpose multi-parameter bedside monitor

Vital Signs Monitor by Edan Instruments, Inc. — 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

K131818 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Edan Instruments, Inc.

Sources (1)

  • FDA UDI c6d0e586-18a6-4a6f-bbe1-e3f926e91ee0 33 fields · synced May 30, 2026