Derma Therapy - DermaTherapy Med Linen;PillowCase-EA - JOERNS HEALTHCARE, LLC

Duns Number:790937150

Device Description: DermaTherapy Med Linen;PillowCase-EA

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More Product Details

Catalog Number

-

Brand Name

Derma Therapy

Version/Model Number

DT-PILL-2030-EA

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

FMW

Product Code Name

Cover, Mattress (Medical Purposes)

Device Record Status

Public Device Record Key

f6bf27ff-f42e-4dc1-a585-f1ccbf1a3809

Public Version Date

June 04, 2020

Public Version Number

1

DI Record Publish Date

May 27, 2020

Additional Identifiers

Package DI Number

20857268006893

Quantity per Package

12

Contains DI Package

00857268006899

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"JOERNS HEALTHCARE, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 164
2 A medical device with a moderate to high risk that requires special controls. 131