Catalog Number

682081

Brand Name

PT 84M(210CM)

Version/Model Number

682081

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

DRS

Product Code Name

Transducer, Blood-Pressure, Extravascular

Public Device Record Key

eeb5e847-67e8-44af-8828-b58e95b5e9b6

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 07, 2016

Package DI Number

50886333620819

Quantity per Package

125

Contains DI Package

00886333620814

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tyvek Pouch