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Vyaire

FDA UDI

Class II (US FDA UDI)

by Jaeger Medical GmbH

Identity

Trade Name
Vyaire FDA UDI
Generic Name
Diagnostic spirometer, professional FDA UDI
Device Name
Spirometry PC Software FDA UDI
Model / Reference
2.5 FDA UDI
Description
Spirometry PC Software FDA UDI

Identifiers

Catalog Number
36-SWR1134 FDA UDI
Primary DI / UDI-DI
04250892904153 FDA UDI
510(k) Number
K141936 FDA UDI
FDA Product Code
BZG FDA UDI
GMDN Term
Diagnostic spirometer, professional FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1840 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Diagnostic spirometer, professional

Vyaire by Jaeger Medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diagnostic spirometer, professional.

Cleared under the same submission

K141936 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Jaeger Medical GmbH

Sources (1)

  • FDA UDI e49d79bd-626c-40a6-a05a-ded664c893ab 36 fields · synced Jun 1, 2026