Catalog Number

-

Brand Name

Axiom® High Capacity

Version/Model Number

111191

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

K770983,K770983,K770983

Product Code

JOL

Product Code Name

Catheter And Tip, Suction

Public Device Record Key

8f7c8c90-6f11-41f7-8ac3-3f0679a097c7

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

M6651111913

Quantity per Package

10

Contains DI Package

M6651111911

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case