Catalog Number

-

Brand Name

VasoPress

Version/Model Number

VP520L

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

K003828,K003828,K003828,K003828,K003828

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

e68be645-4a17-4bf8-a6b7-d386d816cc35

Public Version Date

October 23, 2018

Public Version Number

4

DI Record Publish Date

September 22, 2016

Package DI Number

40815245010626

Quantity per Package

2880

Contains DI Package

00815245010581

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-