Clever Choice - Anti-Static Holding Chamber for use with MDIs. - SIMPLE DIAGNOSTICS INC

Duns Number:004135503

Device Description: Anti-Static Holding Chamber for use with MDIs. Adult Sized Mask included.

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More Product Details

Catalog Number

-

Brand Name

Clever Choice

Version/Model Number

Large Anti-Static Holding Chamber

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"

Yes

For Single-Use

-

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 Details

Product Code

NVP

Product Code Name

Holding Chambers, Direct Patient Interface

Device Record Status

Public Device Record Key

2cc0f0d1-fb63-4a92-9d54-24684940b54a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 07, 2017

Additional Identifiers

Package DI Number

10898302001385

Quantity per Package

12

Contains DI Package

00898302001388

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"SIMPLE DIAGNOSTICS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 19