COSMED - The COSMED Pony FX pulmonary function testing - C O S M E D SRL

Duns Number:438896136

Device Description: The COSMED Pony FX pulmonary function testing system is a standalone and modular laborator The COSMED Pony FX pulmonary function testing system is a standalone and modular laboratory device for performing the basic lung function tests (Basic Spirometry: Forced Vital Capacity, Slow Vital Capacity, Maximum Voluntary Ventilation) and pulse oximetry.

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More Product Details

Catalog Number

-

Brand Name

COSMED

Version/Model Number

Pony FX Flowsafe

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K040549

Product Code Details

Product Code

BTY

Product Code Name

Calculator, Predicted Values, Pulmonary Function

Device Record Status

Public Device Record Key

4d54280a-5ce7-460f-9a22-27c25d64c31d

Public Version Date

March 08, 2022

Public Version Number

5

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"C O S M E D SRL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 22