Catalog Number

-

Brand Name

Vapotherm

Version/Model Number

ProSoft-XL

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

-

Product Code

CAT

Product Code Name

Cannula, Nasal, Oxygen

Public Device Record Key

9017dedd-6660-4689-990d-ab47d7d82d73

Public Version Date

March 22, 2022

Public Version Number

3

DI Record Publish Date

March 27, 2019

Package DI Number

10841737102929

Quantity per Package

10

Contains DI Package

00841737102922

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-