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3100 Hfov

FDA UDI

Class III (US FDA UDI)

by Vyaire Medical, Inc.

Identity

Trade Name
3100 HFOV FDA UDI
Generic Name
Oxygen/air breathing gas mixer, hospital FDA UDI
Device Name
MICROBLENDER,W/2'/3' H,H/L,HFOV FDA UDI
Model / Reference
10273 FDA UDI
Description
MICROBLENDER,W/2'/3' H,H/L,HFOV FDA UDI

Identifiers

Catalog Number
10273 FDA UDI
Primary DI / UDI-DI
10190752160804 FDA UDI
PMA Number
P890057 FDA UDI
FDA Product Code
LSZ FDA UDI
GMDN Term
Oxygen/air breathing gas mixer, hospital FDA UDI

Classification

Device Class
Class III 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

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

Yes

FDA UDI

Category: Oxygen/air breathing gas mixer, hospital

3100 Hfov by Vyaire Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

P890057 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vyaire Medical, Inc.

Sources (1)

  • FDA UDI 8287d216-6980-428b-a9ba-b5636f9798f4 36 fields · synced May 30, 2026