Catalog Number

-

Brand Name

VIVIT

Version/Model Number

810Y

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OEA

Product Code Name

Non-Surgical Isolation Gown

Public Device Record Key

5bc4faea-ac67-4e6d-9483-1cb854c6113e

Public Version Date

November 08, 2021

Public Version Number

1

DI Record Publish Date

October 30, 2021

Package DI Number

20810084210370

Quantity per Package

10

Contains DI Package

10810084210373

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case