WeCare Response Bed - JOERNS WECARE FULL-ELEC HILO BED-BASE - JOERNS HEALTHCARE, LLC

Duns Number:790937150

Device Description: JOERNS WECARE FULL-ELEC HILO BED-BASE

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More Product Details

Catalog Number

WECC-WECARE-BASE

Brand Name

WeCare Response Bed

Version/Model Number

WECC-WECARE-BASE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

FNL

Product Code Name

Bed, Ac-Powered Adjustable Hospital

Device Record Status

Public Device Record Key

f3d71d7b-e6ca-4bf2-a9df-39f2b91d793a

Public Version Date

April 15, 2022

Public Version Number

1

DI Record Publish Date

April 07, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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