Catalog Number

-

Brand Name

AIROS

Version/Model Number

8-ML01

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"

Yes

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

-

Product Code

JOW

Product Code Name

SLEEVE, LIMB, COMPRESSIBLE

Public Device Record Key

c33b8a2f-5ec8-4db7-a61a-8db74db20d97

Public Version Date

January 22, 2020

Public Version Number

2

DI Record Publish Date

November 01, 2019

Package DI Number

10855682007192

Quantity per Package

10

Contains DI Package

00855682007195

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case