Nebulizer,pacifier - Nebulizer,pacifier - BESMED HEALTH BUSINESS CORP.

Duns Number:658023775

Device Description: Nebulizer,pacifier

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More Product Details

Catalog Number

-

Brand Name

Nebulizer,pacifier

Version/Model Number

MP-79120

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

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

BYP

Product Code Name

Mouthpiece, Breathing

Device Record Status

Public Device Record Key

78643333-a986-4c15-8660-03f7e5bde228

Public Version Date

March 23, 2020

Public Version Number

3

DI Record Publish Date

December 13, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BESMED HEALTH BUSINESS CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 289
2 A medical device with a moderate to high risk that requires special controls. 217