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Vyaire

FDA UDI

Class II (US FDA UDI)

by Jaeger Medical GmbH

Identity

Trade Name
Vyaire FDA UDI
Generic Name
Pulmonary function analysis system, paediatric FDA UDI
Device Name
"Squeeze Jacket, size XXS, colour yellow" FDA UDI
Model / Reference
852760 FDA UDI
Description
"Squeeze Jacket, size XXS, colour yellow" FDA UDI

Identifiers

Catalog Number
852760 FDA UDI
Primary DI / UDI-DI
14250892906178 FDA UDI
510(k) Number
K081823 FDA UDI
FDA Product Code
CCM FDA UDI
GMDN Term
Pulmonary function analysis system, paediatric FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1750 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: Pulmonary function analysis system, paediatric

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

Similar devices

Also classified as Pulmonary function analysis system, paediatric.

Cleared under the same submission

K081823 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 8b948243-228f-43c4-b2b9-620cd8f7fae8 37 fields · synced Jun 6, 2026