Micitech

FDA UDI

Class II (US FDA UDI)

by Foshan MIC Medical Technology Co., LTD.

Identity

Trade Name: MICITECH FDA UDI
Generic Name: Mobile/portable oxygen concentrator FDA UDI
Device Name: OXYGEN CONCENTRATOR(Model: CP503), 32 lbs, White, to provide supplemental oxygen to patients with respiratory disorders. FDA UDI
Model / Reference: CP503 FDA UDI
Description: OXYGEN CONCENTRATOR(Model: CP503), 32 lbs, White, to provide supplemental oxygen to patients with respiratory disorders. FDA UDI

Identifiers

Primary DI / UDI-DI: 00860012953325 FDA UDI
510(k) Number: K202389 FDA UDI
FDA Product Code: CAW FDA UDI
GMDN Term: Mobile/portable oxygen concentrator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5440 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

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Mobile/portable oxygen concentrator

Micitech by Foshan MIC Medical Technology Co., LTD. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K202389 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: Foshan MIC Medical Technology Co., LTD.

Sources (1)

FDA UDI b7155078-96a0-4992-8fe8-3f3e4df91762 34 fields · synced Jun 1, 2026