Vapotherm - Oxygen Assist Module Nellcor, UKIT Philippines - VAPOTHERM, INC.

Duns Number:040429050

Device Description: Oxygen Assist Module Nellcor, UKIT Philippines Version

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Vapotherm

Version/Model Number

OAM-NEL-UKIT-PH

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

BTT

Product Code Name

Humidifier, Respiratory Gas, (Direct Patient Interface)

Device Record Status

Public Device Record Key

d239d0cf-aec4-47f9-b1f8-0a8d6434f4ee

Public Version Date

October 10, 2022

Public Version Number

2

DI Record Publish Date

December 13, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VAPOTHERM, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 41
2 A medical device with a moderate to high risk that requires special controls. 229