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Vyaire

FDA UDI

Class II (US FDA UDI)

by Jaeger Medical GmbH

Identity

Trade Name
Vyaire FDA UDI
Generic Name
Cardiopulmonary stress exercise monitoring system FDA UDI
Device Name
Adapter between breahting mask and DVT FDA UDI
Model / Reference
705675 FDA UDI
Description
Adapter between breahting mask and DVT FDA UDI

Identifiers

Catalog Number
705675 FDA UDI
Primary DI / UDI-DI
14250892904419 FDA UDI
510(k) Number
K150810 FDA UDI
FDA Product Code
BZC FDA UDI
GMDN Term
Cardiopulmonary stress exercise monitoring system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1880 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cardiopulmonary stress exercise monitoring system

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

Similar devices

Also classified as Cardiopulmonary stress exercise monitoring system.

Cleared under the same submission

K150810 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 ec6c1a86-2139-4ef7-8919-d823f8a67610 37 fields · synced Jun 6, 2026