EZ-MISTER Disposable Atomizer - N. M. BEALE COMPANY, INC.

Duns Number:780056289

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More Product Details

Catalog Number

EZ24

Brand Name

EZ-MISTER Disposable Atomizer

Version/Model Number

EZ24

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2017

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"

-

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 Details

Product Code

CCT

Product Code Name

Applicator (Laryngo-Tracheal), Topical Anesthesia

Device Record Status

Public Device Record Key

99293cc8-89eb-43e0-8083-6a88c3f0ff3e

Public Version Date

March 18, 2020

Public Version Number

4

DI Record Publish Date

December 07, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"N. M. BEALE COMPANY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 6