Catalog Number

-

Brand Name

AQUIST WASHABLE ISOLATION GOWN

Version/Model Number

6070553481

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

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

6c2d00f5-1558-4878-bdcd-c61a018ebe01

Public Version Date

October 28, 2022

Public Version Number

1

DI Record Publish Date

October 20, 2022

Package DI Number

D89260705534812

Quantity per Package

60

Contains DI Package

D89260705534811

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case