VOCSN Travel Suction Canister - VOCSN Travel Suction Canister - VENTEC LIFE SYSTEMS, INC.

Duns Number:078758082

Device Description: VOCSN Travel Suction Canister

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More Product Details

Catalog Number

PRT-00824-001

Brand Name

VOCSN Travel Suction Canister

Version/Model Number

PRT-00824-000

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

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

K162877,K162877

Product Code Details

Product Code

BTA

Product Code Name

Pump, Portable, Aspiration (Manual Or Powered)

Device Record Status

Public Device Record Key

58955e25-b212-40e9-8bf2-79c91ac9ab88

Public Version Date

January 31, 2019

Public Version Number

6

DI Record Publish Date

November 11, 2017

Additional Identifiers

Package DI Number

00855573007143

Quantity per Package

10

Contains DI Package

00855573007129

Package Discontinue Date

-

Package Status

In Commercial Distribution

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