LMA ATOMIZATION - MADomizer Replacement Bottle Clip - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: MADomizer Replacement Bottle Clip

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

MAD520

Brand Name

LMA ATOMIZATION

Version/Model Number

IPN048833

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

CCQ

Product Code Name

NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)

Device Record Status

Public Device Record Key

b0283333-9cbc-4aea-9ea9-807a716d6861

Public Version Date

June 08, 2021

Public Version Number

2

DI Record Publish Date

September 15, 2018

Additional Identifiers

Package DI Number

24026704613179

Quantity per Package

5

Contains DI Package

14026704613172

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"TELEFLEX INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3195
2 A medical device with a moderate to high risk that requires special controls. 13747
3 A medical device with high risk that requires premarket approval 3
U Unclassified 26