CARDINAL HEALTH - Hovertech Hovermatt Lateral Transfer Mattress - Cardinal Health, Inc.

Duns Number:080935429

Device Description: Hovertech Hovermatt Lateral Transfer Mattress

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More Product Details

Catalog Number

ST-HM50SPU-B

Brand Name

CARDINAL HEALTH

Version/Model Number

ST-HM50SPU-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)

Yes

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

FRZ

Product Code Name

DEVICE, PATIENT TRANSFER, POWERED

Device Record Status

Public Device Record Key

fe706f9f-46c2-413f-94dd-f43894152535

Public Version Date

October 11, 2019

Public Version Number

1

DI Record Publish Date

October 03, 2019

Additional Identifiers

Package DI Number

50885380168527

Quantity per Package

5

Contains DI Package

10885380168529

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"CARDINAL HEALTH, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 672
2 A medical device with a moderate to high risk that requires special controls. 1692
U Unclassified 17