Catalog Number

188414

Brand Name

Pulmonary Function Test Kit B, VBMax 48 MM

Version/Model Number

Pulmonary Function Test Kit B, Disposable, VBMax 48 MM - 188414

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

3cea2452-6c83-4af6-8025-ad5509244828

Public Version Date

August 02, 2022

Public Version Number

1

DI Record Publish Date

July 25, 2022

Package DI Number

00817081027327

Quantity per Package

100

Contains DI Package

00817081027310

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-