Catalog Number

-

Brand Name

Mespere

Version/Model Number

IS-01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 30, 2018

Issuing Agency

In HIBCC

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K151776

Product Code

PFA

Product Code Name

Non-Invasive Central Venous Manometer

Public Device Record Key

612ddf98-579f-4d9c-b212-294b2bcfc66a

Public Version Date

May 06, 2020

Public Version Number

5

DI Record Publish Date

October 06, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-