Catalog Number

9119015

Brand Name

ASP AEROFLEX

Version/Model Number

9119015

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K181472

Product Code

FEB

Product Code Name

Accessories, cleaning, for endoscope

Public Device Record Key

1adc963e-5c6c-4e2a-b193-d46671d78a18

Public Version Date

December 11, 2020

Public Version Number

2

DI Record Publish Date

July 31, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-