Catalog Number

498447

Brand Name

Arterial Line Kit/1

Version/Model Number

498447

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

08eaa55a-c568-4218-ba82-86b36369c6dd

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 09, 2016

Package DI Number

20886333215762

Quantity per Package

10

Contains DI Package

00886333215768

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box