Diagnostix™

FDA UDI

Class II (US FDA UDI)

by American Diagnostic Corporation

Identity

Trade Name: Diagnostix™ FDA UDI
Generic Name: Pulse oximeter FDA UDI
Device Name: DIAGNOSTIX Pulse Oximeter,Fingertip, w/Orange bumper FDA UDI
Model / Reference: 2100OR FDA UDI
Description: DIAGNOSTIX Pulse Oximeter,Fingertip, w/Orange bumper FDA UDI

Identifiers

Catalog Number: 2100OR FDA UDI
Primary DI / UDI-DI: 00634782063627 FDA UDI
510(k) Number: K101577 FDA UDI
FDA Product Code: DQA FDA UDI
GMDN Term: Pulse oximeter 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Pulse oximeter

Diagnostix™ by American Diagnostic Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Pulse oximeter.

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Curaplex — BOUND TREE MEDICAL, LLC · Class II
ChoiceMMed — Beijing Choice Electronic Technology Co., Ltd. · Class II
ChoiceMMed — Beijing Choice Electronic Technology Co., Ltd. · Class II

Cleared under the same submission

K101577 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: American Diagnostic Corporation

Sources (1)

FDA UDI 77f1f990-a4ac-440e-b8fd-508474d1188e 38 fields · synced May 30, 2026