Catalog Number

-

Brand Name

PURE ENRICHMENT

Version/Model Number

PEPNGN

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

-

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

763fd134-f133-4746-bb5a-3999740605f7

Public Version Date

November 17, 2020

Public Version Number

1

DI Record Publish Date

November 09, 2020

Package DI Number

B311PEPNGN1

Quantity per Package

24

Contains DI Package

B311PEPNGN0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

MASTER CARTON