Catalog Number

SLP001

Brand Name

SLP001

Version/Model Number

SLP001

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

KMK

Product Code Name

DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Public Device Record Key

8386183b-28dc-4bec-9250-fa9036e68371

Public Version Date

July 22, 2019

Public Version Number

2

DI Record Publish Date

January 25, 2019

Package DI Number

20801741182826

Quantity per Package

10

Contains DI Package

10801741182829

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX