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Maxblend 2

FDA UDI

Class II (US FDA UDI)

by Maxtec, Inc.

Identity

Trade Name
MAXBLEND 2 FDA UDI
Generic Name
Oxygen/air breathing gas mixer, hospital FDA UDI
Device Name
MAXBLEND2, 0-3 LPM, BMD W/ DISS, 50PSI FDA UDI
Model / Reference
R229P01-013 FDA UDI
Description
MAXBLEND2, 0-3 LPM, BMD W/ DISS, 50PSI FDA UDI

Identifiers

Primary DI / UDI-DI
00817770021223 FDA UDI
510(k) Number
K161718 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
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

Maxblend 2 by Maxtec, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K161718 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 797c8244-b603-4d6c-809c-8b8175e8fe39 35 fields · synced May 30, 2026