Catalog Number

-

Brand Name

Equate Space Chamber

Version/Model Number

V1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NVP

Product Code Name

Holding Chambers, Direct Patient Interface

Public Device Record Key

5cc7c3e9-0765-4eae-9a4b-6c888665abd8

Public Version Date

January 09, 2020

Public Version Number

1

DI Record Publish Date

January 01, 2020

Package DI Number

10681131240717

Quantity per Package

48

Contains DI Package

00681131240710

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer shipper