Catalog Number

187170

Brand Name

Pulmonary Function Test Kit J, VBMax 30s

Version/Model Number

Pulmonary Function Test Kit J - 187170

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

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

K000654,K000654

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

bb3509f8-6b3b-4f2d-89f2-d78295b54d2c

Public Version Date

September 29, 2020

Public Version Number

1

DI Record Publish Date

September 21, 2020

Package DI Number

00817081026856

Quantity per Package

100

Contains DI Package

00817081026849

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-