Catalog Number

-

Brand Name

Centricity

Version/Model Number

Perinatal 6.98

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K111614

Product Code

HGM

Product Code Name

SYSTEM, MONITORING, PERINATAL

Public Device Record Key

7f649534-aa95-4058-98cb-0d3d90618495

Public Version Date

October 27, 2022

Public Version Number

5

DI Record Publish Date

November 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-