VOCSN High Flow Kit - The Ventec High Flow Nasal Cannula Kit contains - VENTEC LIFE SYSTEMS, INC.

Duns Number:078758082

Device Description: The Ventec High Flow Nasal Cannula Kit contains the following items:- 5x Adult, Valveless

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More Product Details

Catalog Number

PRT-01305-000

Brand Name

VOCSN High Flow Kit

Version/Model Number

5-Week High Flow Nasal Cannula Kit

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

BTT

Product Code Name

Humidifier, Respiratory Gas, (Direct Patient Interface)

Device Record Status

Public Device Record Key

0f329692-c54a-4a93-88bd-f08c321b7656

Public Version Date

March 03, 2021

Public Version Number

1

DI Record Publish Date

February 23, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VENTEC LIFE SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 43