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SmartHeart

FDA UDI

Class II (US FDA UDI)

by Veridian Healthcare

Identity

Trade Name
SmartHeart FDA UDI
Generic Name
Pulse oximeter probe, reusable FDA UDI
Device Name
SmartHeart Talking Pulse Oximeter FDA UDI
Model / Reference
11-50L FDA UDI
Description
SmartHeart Talking Pulse Oximeter FDA UDI

Identifiers

Catalog Number
11-50L FDA UDI
Primary DI / UDI-DI
00845717006811 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

Yes

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Pulse oximeter probe, reusable

SmartHeart by Veridian Healthcare — 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
Veridian Healthcare

Sources (1)

  • FDA UDI 4ce0e390-14c4-453f-ae70-d7db42f0dc2f 35 fields · synced May 30, 2026