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3100b Hfov

FDA UDI

Class III (US FDA UDI)

by Vyaire Medical, Inc.

Identity

Trade Name
3100B HFOV FDA UDI
Generic Name
Stationary electric high-frequency ventilator FDA UDI
Device Name
3100B VENT ASSY,220V/50HZ FDA UDI
Model / Reference
771453 FDA UDI
Description
3100B VENT ASSY,220V/50HZ FDA UDI

Identifiers

Catalog Number
771453 FDA UDI
Primary DI / UDI-DI
10190752155442 FDA UDI
PMA Number
P890057 FDA UDI
FDA Product Code
LSZ FDA UDI
GMDN Term
Stationary electric high-frequency ventilator 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

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

Yes

FDA UDI

Category: Stationary electric high-frequency ventilator

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

Similar devices

Also classified as Stationary electric high-frequency ventilator.

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 6e4e7e31-5ba4-41c2-87f4-5d8c017fd59b 36 fields · synced Jun 8, 2026