Catalog Number

622272

Brand Name

ASEPT®

Version/Model Number

622272

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

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

K001716,K001716

Product Code

JCX

Product Code Name

APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Public Device Record Key

11982ee6-fdb6-459c-9179-e4b32ea402a7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-