MicroMax

FDA UDI

Class II (US FDA UDI)

by Maxtec, Inc.

Identity

Trade Name: MicroMax FDA UDI
Generic Name: Oxygen/air breathing gas mixer, hospital FDA UDI
Device Name: MicroMax High Flow Blender with NIST fitting FDA UDI
Model / Reference: R203P14-001 FDA UDI
Description: MicroMax High Flow Blender with NIST fitting FDA UDI

Identifiers

Primary DI / UDI-DI: 00853061006203 FDA UDI
510(k) Number: K053232 FDA UDI
FDA Product Code: BZR FDA UDI
GMDN Term: Oxygen/air breathing gas mixer, hospital FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5330 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

FDA UDI

Category: Oxygen/air breathing gas mixer, hospital

MicroMax by Maxtec, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oxygen/air breathing gas mixer, hospital.

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Bio-Med Devices, Inc. — Bio-Med Devices, Inc. · Class II
Bio-Med Devices, Inc. — Bio-Med Devices, Inc. · Class II
Sechrist Industries, Inc. — Sechrist Industries Inc · Class II
Blender — VYAIRE MEDICAL, INC. · Class II
Sechrist Industries, Inc. — Sechrist Industries Inc · Class II
Bio-Med Devices, Inc. — Bio-Med Devices, Inc. · Class II
Bio-Med Devices, Inc. — Bio-Med Devices, Inc. · Class II

Cleared under the same submission

K053232 also covers:

MicroMax — Maxtec, Inc.
MicroMax — Maxtec, Inc.
MicroMax Blender — Maxtec, Inc.
Micromax — Maxtec, Inc.
Precision Medical Inc. — PRECISION MEDICAL, INC.

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: Maxtec, Inc.

Sources (1)

FDA UDI 2aa49c02-c900-4ef2-9095-5f5c3afeb23c 34 fields · synced Jun 1, 2026