Catalog Number

682078

Brand Name

PT48M(120CM)

Version/Model Number

682078

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

5676ba21-687a-46cf-82cf-1938bb7648a9

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 22, 2016

Package DI Number

50886333620789

Quantity per Package

125

Contains DI Package

00886333620784

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tyvek Pouch