Catalog Number

6982

Brand Name

PKIT, AXIS, 5 IN. GT, SG, W/TUBING

Version/Model Number

6982-1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

CCX

Product Code Name

Support, Patient Position

Public Device Record Key

51639800-9ecb-4c56-9b65-4c9b6c838c2a

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

September 09, 2020

Package DI Number

10842430114240

Quantity per Package

6

Contains DI Package

00842430114243

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case