Catalog Number

-

Brand Name

PURE ENRICHMENT

Version/Model Number

PEFETDPL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K131457,K131457

Product Code

KNG

Product Code Name

Monitor, Ultrasonic, Fetal

Public Device Record Key

a341b9c0-2744-4ac2-a8ad-644ead929b26

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 20, 2017

Package DI Number

B311PEFETDPL1

Quantity per Package

20

Contains DI Package

B311PEFETDPL0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

MASTER CARTON