Catalog Number

-

Brand Name

Axiom®

Version/Model Number

515NS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

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

GAZ

Product Code Name

Tubing, Noninvasive

Public Device Record Key

af855124-6dcb-4cf4-a533-988dc4ffb3f2

Public Version Date

June 08, 2021

Public Version Number

2

DI Record Publish Date

November 13, 2020

Package DI Number

M665515NS1

Quantity per Package

1

Contains DI Package

M665515NS0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag