Catalog Number

498412BLF

Brand Name

Arterial Line Kit

Version/Model Number

498412BLF

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"

-

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

K780871,K780871

Product Code

GDY

Product Code Name

Gauze/Sponge, Internal, X-Ray Detectable

Public Device Record Key

d7ad7381-8546-4999-b6b0-7c7d7f6cf8d7

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

April 24, 2018

Package DI Number

20886333224184

Quantity per Package

10

Contains DI Package

00886333224180

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box