Catalog Number

-

Brand Name

Vapotherm

Version/Model Number

PFH-UKIT-C-ZA

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

Product Code

BTT

Product Code Name

Humidifier, Respiratory Gas, (Direct Patient Interface)

Public Device Record Key

eaf80313-f8bf-41ed-9bf0-929229bf05c6

Public Version Date

October 10, 2022

Public Version Number

2

DI Record Publish Date

December 13, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-