Catalog Number

-

Brand Name

Vapotherm

Version/Model Number

PF-WBA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K072845,K111640,K072845,K111640

Product Code

BTT

Product Code Name

Humidifier, Respiratory Gas, (Direct Patient Interface)

Public Device Record Key

0209171b-671d-4ed9-beaf-b6ba6a1aee16

Public Version Date

October 10, 2022

Public Version Number

6

DI Record Publish Date

March 20, 2018

Package DI Number

10841737100734

Quantity per Package

25

Contains DI Package

00841737100737

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case