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Avea

FDA UDI

Class II (US FDA UDI)

by Vyaire Medical, Inc.

Identity

Trade Name
AVEA FDA UDI
Generic Name
Uninterruptible power supply FDA UDI
Device Name
FLOW SENSOR,INSPIRATORY ASSEMBLY FDA UDI
Model / Reference
51000-40043 FDA UDI
Description
FLOW SENSOR,INSPIRATORY ASSEMBLY FDA UDI

Identifiers

Catalog Number
51000-40043 FDA UDI
Primary DI / UDI-DI
10190752177048 FDA UDI
510(k) Number
K103211 FDA UDI
FDA Product Code
CBK FDA UDI
GMDN Term
Uninterruptible power supply FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5895 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: Uninterruptible power supply

Avea by Vyaire Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Uninterruptible power supply.

Cleared under the same submission

K103211 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 41985c39-30a6-4131-bf2f-98d2a61408db 36 fields · synced Jun 8, 2026