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Jaeger

FDA UDI

Class II (US FDA UDI)

by Jaeger Medical GmbH

Identity

Trade Name
Jaeger FDA UDI
Generic Name
Pulmonary function analysis system, paediatric FDA UDI
Device Name
MasterScreen PAED FDA UDI
Model / Reference
V-171500-13 FDA UDI
Description
MasterScreen PAED FDA UDI

Identifiers

Catalog Number
V-171500-13 FDA UDI
Primary DI / UDI-DI
04250892905013 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Pulmonary function analysis system, paediatric

Jaeger 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 1b699569-2926-4b6d-a903-d26ca3f5421a 37 fields · synced May 29, 2026