Pure Enrichment - BEAR DOWN CONSULTING

Duns Number:040869867

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More Product Details

Catalog Number

-

Brand Name

Pure Enrichment

Version/Model Number

PEWTPLRG-L

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

IRT

Product Code Name

Pad, Heating, Powered

Device Record Status

Public Device Record Key

9563b278-0161-4d65-91e2-3452e052dcab

Public Version Date

July 07, 2020

Public Version Number

2

DI Record Publish Date

January 13, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BEAR DOWN CONSULTING" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 56