Catalog Number

V-175420-13

Brand Name

Jaeger

Version/Model Number

V-175420-13

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 21, 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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

BZC

Product Code Name

Calculator, Pulmonary Function Data

Public Device Record Key

c55a89cf-e2bc-4499-af62-027a786a82d9

Public Version Date

March 16, 2021

Public Version Number

5

DI Record Publish Date

August 02, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-