Catalog Number

PRT-01030-000

Brand Name

VOCSN External Suction Canister Adapter

Version/Model Number

PRT-01030-000

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"

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

BTA

Product Code Name

Pump, Portable, Aspiration (Manual Or Powered)

Public Device Record Key

ca92ad9b-7d40-47a6-9eb9-0394a37e86c0

Public Version Date

March 04, 2019

Public Version Number

1

DI Record Publish Date

January 30, 2019

Package DI Number

00855573007457

Quantity per Package

5

Contains DI Package

00855573007464

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-