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Bellavista

FDA UDI

Class II (US FDA UDI)

by Vyaire Medical, Inc.

Identity

Trade Name
Bellavista FDA UDI
Generic Name
Respiration monitor FDA UDI
Device Name
Diagnostic Package Capnography Sidestream FDA UDI
Model / Reference
302.323.000 FDA UDI
Description
Diagnostic Package Capnography Sidestream FDA UDI

Identifiers

Primary DI / UDI-DI
10190752188921 FDA UDI
510(k) Number
K183364 FDA UDI
FDA Product Code
CBK FDA UDI
GMDN Term
Respiration monitor 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Electrical-only medical device connection cable, reusableRespiration monitor

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

Similar devices

Also classified as Respiration monitor.

Cleared under the same submission

K183364 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 1e3e0aa3-dca1-4a34-a992-091eb38336d1 36 fields · synced May 30, 2026