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HealthSmart

FDA UDI

Class II (US FDA UDI)

by Dms Holdings, Inc.,

Identity

Trade Name
HealthSmart FDA UDI
Generic Name
Pulse oximeter probe, reusable FDA UDI
Device Name
Digital Standard Fingertip Pulse Oximeter - Green Display FDA UDI
Model / Reference
40-816-000 FDA UDI
Description
Digital Standard Fingertip Pulse Oximeter - Green Display FDA UDI

Identifiers

Primary DI / UDI-DI
00767056180260 FDA UDI
FDA Product Code
OCH FDA UDI
GMDN Term
Pulse oximeter probe, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2700 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Pulse oximeter probe, reusable

HealthSmart by Dms Holdings, Inc., — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pulse oximeter probe, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dms Holdings, Inc.,

Sources (1)

  • FDA UDI 0f3235f8-c178-4974-8aff-4b5d9a885638 33 fields · synced Jun 8, 2026