LMA ATOMIZATION - MAD Nasal without Syringe - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: MAD Nasal without Syringe

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More Product Details

Catalog Number

MAD300

Brand Name

LMA ATOMIZATION

Version/Model Number

IPN046388

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

b6f32b70-32e1-4e53-8381-fac4dca4e766

Public Version Date

June 08, 2021

Public Version Number

3

DI Record Publish Date

September 15, 2018

Additional Identifiers

Package DI Number

25060112313053

Quantity per Package

4

Contains DI Package

15060112313056

Package Discontinue Date

September 30, 2019

Package Status

Not 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