WeCare Response Bed - WeCare Response Bed, Manual, No Panels - JOERNS HEALTHCARE, LLC

Duns Number:790937150

Device Description: WeCare Response Bed, Manual, No Panels

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More Product Details

Catalog Number

WECC-RESP-BD

Brand Name

WeCare Response Bed

Version/Model Number

WECC-RESP-BD

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

FNJ

Product Code Name

Bed, Manual

Device Record Status

Public Device Record Key

91fb9579-9cac-421b-8f16-44505e1d7ee9

Public Version Date

September 29, 2020

Public Version Number

1

DI Record Publish Date

September 21, 2020

Additional Identifiers

Package DI Number

20810055880168

Quantity per Package

5

Contains DI Package

00810055880164

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