VOCSN - V+C+Pro, Japanese: The VOCSN Unified Respiratory - VENTEC LIFE SYSTEMS, INC.

Duns Number:078758082

Device Description: V+C+Pro, Japanese: The VOCSN Unified Respiratory System is intended to provide continuous

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More Product Details

Catalog Number

PRT-00900-100

Brand Name

VOCSN

Version/Model Number

V+C+Pro, Japanese

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"

Yes

For Single-Use

-

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

K162877,K162877

Product Code Details

Product Code

BZE

Product Code Name

Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Device Record Status

Public Device Record Key

19b55e01-185e-4bce-90b1-d785205043bf

Public Version Date

April 20, 2022

Public Version Number

1

DI Record Publish Date

April 12, 2022

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