HoverMatt Lateral Transfer Mattress - HoverMatt Lateral Transfer Mattress HM34SPU-LNK-B - RENU MEDICAL, INC

Duns Number:100439103

Device Description: HoverMatt Lateral Transfer Mattress HM34SPU-LNK-B

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More Product Details

Catalog Number

-

Brand Name

HoverMatt Lateral Transfer Mattress

Version/Model Number

RM-HM34SPU-LNK-B

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

Yes

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

FMR

Product Code Name

Device, Transfer, Patient, Manual

Device Record Status

Public Device Record Key

604e7a15-c61a-4c4e-bd2a-b6905cac9e08

Public Version Date

October 19, 2021

Public Version Number

3

DI Record Publish Date

June 27, 2019

Additional Identifiers

Package DI Number

10816317023543

Quantity per Package

10

Contains DI Package

00816317023546

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"RENU MEDICAL, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 68
2 A medical device with a moderate to high risk that requires special controls. 95