Soma Safe Enclosure - Frame for structural support of a canopy to - VIVAX MEDICAL CORPORATION

Duns Number:154815062

Device Description: Frame for structural support of a canopy to prevent patient from exiting bed unassisted

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More Product Details

Catalog Number

-

Brand Name

Soma Safe Enclosure

Version/Model Number

SSE 450

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

20dc2770-fec5-41a8-aea5-33c9b5e99fab

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 04, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VIVAX MEDICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 9