Spiro PD - The Spiro PD personal spirometer is a hand held - PMD HEALTHCARE, INC.

Duns Number:003229849

Device Description: The Spiro PD personal spirometer is a hand held device that is used to test the user’s lun The Spiro PD personal spirometer is a hand held device that is used to test the user’s lung capacity. Measures of air flow and volume are indicators of lung health. By blowing into the tube of the Spiro PD the user can see a measure of his/her forced expiratory volume for one second (FEV1), forced vital capacity (FVC), FEV1/FVC ratio, peak expiratory flow (PEF), and forced expiratory flow from 25% to 75% (FEF 25/75). The SPIRO PD spirometer is intended to be used by a patient under the instruction of a physician or respiratory therapist to test lung function in child, adolescent and adult. It is intended to be used as a single-patient device only and can be used in any setting - home, factory, hospital or physician's office. The SPIRO PD spirometer is indicated for the following age groups: • 2-12 years - Child • 13-21 years - Adolescent • 22 and over- Adult.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

10000101

Brand Name

Spiro PD

Version/Model Number

1.0

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

K103575

Product Code Details

Product Code

BZG

Product Code Name

Spirometer, Diagnostic

Device Record Status

Public Device Record Key

ea898773-5131-48b8-88d4-e303ddba615a

Public Version Date

March 08, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PMD HEALTHCARE, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1