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Avea™

FDA UDI

Class II (US FDA UDI)

by Vyaire Medical, Inc.

Identity

Trade Name
AVEA™ FDA UDI
Generic Name
Breathing circuit gas-flow sensor, reusable FDA UDI
Device Name
AVEA CAPNOGRAPHY KIT FDA UDI
Model / Reference
11732 FDA UDI
Description
AVEA CAPNOGRAPHY KIT FDA UDI

Identifiers

Catalog Number
11732 FDA UDI
Primary DI / UDI-DI
10190752158351 FDA UDI
10190752199996 FDA UDI
510(k) Number
K103211 FDA UDI
FDA Product Code
CBK FDA UDI
GMDN Term
Breathing circuit gas-flow sensor, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5895 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI
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

Yes

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

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 (2)

  • FDA UDI 954760da-4f93-44cc-9960-4f401bcf524c 37 fields · synced Jun 6, 2026
  • FDA UDI f9b2f158-23c1-4d1f-879b-05c42067d216 36 fields · synced May 24, 2026