Catalog Number

682110

Brand Name

TA2100 ANGIOGRAPHIC MANIFOLD

Version/Model Number

682110

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

57f29602-3d63-4de0-b6d1-a27fb3e2c2d2

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 25, 2016

Package DI Number

50886333621106

Quantity per Package

125

Contains DI Package

00886333621101

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tyvek bag