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Maxo2+ae International

FDA UDI

Class II (US FDA UDI)

by Maxtec, Inc.

Identity

Trade Name
MAXO2+AE INTERNATIONAL FDA UDI
Generic Name
Respiratory oxygen monitor, line-powered FDA UDI
Device Name
Oxygen Analyzer Ohio Medical Labeled MiniOx 200E International FDA UDI
Model / Reference
R217P72-006 FDA UDI
Description
Oxygen Analyzer Ohio Medical Labeled MiniOx 200E International FDA UDI

Identifiers

Primary DI / UDI-DI
00817770021315 FDA UDI
510(k) Number
K040484 FDA UDI
FDA Product Code
CCL FDA UDI
GMDN Term
Respiratory oxygen monitor, line-powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1720 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Maxo2+ae International by Maxtec, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K040484 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Maxtec, Inc.

Sources (1)

  • FDA UDI 495fcdd2-8abe-41f3-890d-9167b9de534f 35 fields · synced May 31, 2026