Compact

FDA UDI

Class II (US FDA UDI)

by Vitalograph Ireland, Ltd.

Identity

Trade Name: Compact FDA UDI
Generic Name: Diagnostic spirometer, professional FDA UDI
Device Name: GENERIC CLINICAL TRIAL CASE - MIP MEP COMPACT(1) FDA UDI
Model / Reference: 6600 FDA UDI
Description: GENERIC CLINICAL TRIAL CASE - MIP MEP COMPACT(1) FDA UDI

Identifiers

Primary DI / UDI-DI: 05099169414846 FDA UDI
FDA Product Code: BZG FDA UDI
BXW FDA UDI
GMDN Term: Diagnostic spirometer, professional FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.1840 FDA UDI
868.1870 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Diagnostic spirometer, professional Spirometer/pulmonary function analyser syringe

Compact by Vitalograph Ireland, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Vitalograph Ireland, Ltd.

Sources (1)

FDA UDI 17a12c7c-05fa-4b1e-9e6e-c9a1af813298 34 fields · synced Jun 1, 2026