Catalog Number

950-245

Brand Name

DISPIRO

Version/Model Number

Custom

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

For Single-Use

Yes

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

K791177,K791177,K791177

Product Code

BZG

Product Code Name

Spirometer, Diagnostic

Public Device Record Key

70f2292d-ae16-40ac-9858-069bbea3c2c4

Public Version Date

December 18, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

H6719502452

Quantity per Package

4

Contains DI Package

H6719502451

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Overpack