Catalog Number

-

Brand Name

McKesson

Version/Model Number

146-RTLPC23346

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

-

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

-

Product Code

KIC

Product Code Name

Cushion, Flotation

Public Device Record Key

5561bc63-cbfc-4869-a7ed-83602568634d

Public Version Date

December 10, 2018

Public Version Number

1

DI Record Publish Date

November 09, 2018

Package DI Number

00612479231399

Quantity per Package

6

Contains DI Package

00612479231382

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case