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HeliO2 Blender

FDA UDI

Class II (US FDA UDI)

by Precision Medical, Inc.

Identity

Trade Name
HeliO2 Blender FDA UDI
Generic Name
Helium/oxygen breathing gas mixer FDA UDI
Device Name
PM5400 SERIES,BLENDER,HE/O2,LOW FLOW,80/20 FDA UDI
Model / Reference
PM5480 FDA UDI
Description
PM5400 SERIES,BLENDER,HE/O2,LOW FLOW,80/20 FDA UDI

Identifiers

Primary DI / UDI-DI
00855887006054 FDA UDI
510(k) Number
K090781 FDA UDI
FDA Product Code
BZR FDA UDI
GMDN Term
Helium/oxygen breathing gas mixer 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Category: Helium/oxygen breathing gas mixer

HeliO2 Blender by Precision Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Helium/oxygen breathing gas mixer.

Cleared under the same submission

K090781 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Precision Medical, Inc.

Sources (1)

  • FDA UDI 0984931a-df7c-4854-bb43-e7e170813a18 35 fields · synced May 30, 2026