Catalog Number

-

Brand Name

Procare Spacer chamber Adult

Version/Model Number

240500

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"

-

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

NVP

Product Code Name

Holding Chambers, Direct Patient Interface

Public Device Record Key

4ee75a01-c442-468d-bd8a-88f64376da4a

Public Version Date

September 16, 2019

Public Version Number

1

DI Record Publish Date

September 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-