Catalog Number

-

Brand Name

Vapotherm

Version/Model Number

MA1700-BR

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

6ed2e360-d74c-4fb6-a2b0-a6011f205cd6

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

October 08, 2020

Package DI Number

10841737103698

Quantity per Package

25

Contains DI Package

00841737103691

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-