Catalog Number

709554

Brand Name

Jaeger

Version/Model Number

709554

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 03, 2019

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K071753

Product Code

BTY

Product Code Name

Calculator, Predicted Values, Pulmonary Function

Public Device Record Key

28957534-e867-4c21-b560-cb55206a5fab

Public Version Date

March 08, 2022

Public Version Number

6

DI Record Publish Date

June 07, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-