Catalog Number

687104

Brand Name

NEONATAL ARTERIAL LINE

Version/Model Number

687104

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

-

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

725e1bfa-2f3c-4df3-b777-5c54bdd6fad5

Public Version Date

June 11, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

50886333671040

Quantity per Package

50

Contains DI Package

00886333671045

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

tyvek bag