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TrueOne 2400

FDA UDI

Class II (US FDA UDI)

by Parvomedics, Incorporated

Identity

Trade Name
TrueOne 2400 FDA UDI
Generic Name
Diagnostic spirometer, professional FDA UDI
Device Name
The TrueOne® 2400 is a compact, integrated metabolic measurement system for cardiopulmonary stress testing, indirect calorimetry, and maximal O2 consumption measurement. FDA UDI
Model / Reference
MMS-2400 FDA UDI
Description
The TrueOne® 2400 is a compact, integrated metabolic measurement system for cardiopulmonary stress testing, indirect calorimetry, and maximal O2 consumption measurement. FDA UDI

Identifiers

Primary DI / UDI-DI
B687MMS240005 FDA UDI
510(k) Number
K941843 FDA UDI
FDA Product Code
BZC FDA UDI
GMDN Term
Diagnostic spirometer, professional 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Diagnostic spirometer, professional

TrueOne 2400 by Parvomedics, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diagnostic spirometer, professional.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Parvomedics, Incorporated

Sources (1)

  • FDA UDI 44d1a8c9-352a-49b0-9439-7086358b3269 34 fields · synced Jun 8, 2026