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Vitals360

FDA UDI

Class II (US FDA UDI)

by Vocare, Inc.

Identity

Trade Name
Vitals360 FDA UDI
Generic Name
Pulse oximeter FDA UDI
Device Name
Vitals360 Multi-Vitals Mobile Monitor VC-001 FDA UDI
Model / Reference
VC-001 FDA UDI
Description
Vitals360 Multi-Vitals Mobile Monitor VC-001 FDA UDI

Identifiers

Primary DI / UDI-DI
00860007323409 FDA UDI
510(k) Number
K210086 FDA UDI
FDA Product Code
MWI FDA UDI
DQA FDA UDI
DSH FDA UDI
DXN FDA UDI
FLL FDA UDI
GMDN Term
Pulse oximeter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2300 FDA UDI
870.2700 FDA UDI
870.2800 FDA UDI
870.1130 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Automatic-inflation electronic sphygmomanometer, portable, arm/wristInfrared patient thermometer, skinPulse oximeterMultiple vital physiological parameter monitoring system, clinical

Vitals360 by Vocare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple vital physiological parameter monitoring system, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vocare, Inc.

Sources (1)

  • FDA UDI 59d04374-ce72-4984-8c77-835c0d9b8b3d 34 fields · synced Jun 8, 2026