Foam Mattress Pads - KING Convolute Mattress Topper 4" X 76" X 80" - GENEVA HEALTHCARE, LLC

Duns Number:964459106

Device Description: KING Convolute Mattress Topper 4" X 76" X 80" Density # 1.2

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More Product Details

Catalog Number

CM-47680D

Brand Name

Foam Mattress Pads

Version/Model Number

CM-47680D

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

CCX

Product Code Name

Support, Patient Position

Device Record Status

Public Device Record Key

bac090be-4e62-4c25-adfd-cd5be188cecd

Public Version Date

July 15, 2020

Public Version Number

2

DI Record Publish Date

February 28, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GENEVA HEALTHCARE, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 148