Catalog Number

049969302D

Brand Name

Keepsafe PA/CVP Kit

Version/Model Number

049969302D

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 03, 2019

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

2ee07702-d189-404a-99d5-ab1d2fce609b

Public Version Date

June 04, 2019

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

20886333203097

Quantity per Package

5

Contains DI Package

00886333203093

Package Discontinue Date

June 03, 2019

Package Status

Not in Commercial Distribution

Package Type

Box