Catalog Number

-

Brand Name

Pressure dome - 30034

Version/Model Number

1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K792020,K792020,K792020

Product Code

DRS

Product Code Name

Transducer, Blood-Pressure, Extravascular

Public Device Record Key

660bde2a-5cbe-423f-90bf-a228de969a84

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

27071977000086

Quantity per Package

12

Contains DI Package

17071977000089

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-