Catalog Number

-

Brand Name

Innocor

Version/Model Number

INN00400-1b

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K051907,K071911,K083879,K102047

Product Code

BZC

Product Code Name

Calculator, Pulmonary Function Data

Public Device Record Key

100bd4c6-08c2-43ff-a88d-3b7e2af8aceb

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 14, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-