NeoSeal Micro - Nasal Seal CPAP (Qty. 150) - Neotech Products LLC

Duns Number:198013435

Device Description: Nasal Seal CPAP (Qty. 150)

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More Product Details

Catalog Number

N420

Brand Name

NeoSeal Micro

Version/Model Number

10812594012164

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"

-

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

BXJ

Product Code Name

Clip, Nose

Device Record Status

Public Device Record Key

960df08c-5b75-43f9-880b-1e20e36e612e

Public Version Date

July 26, 2022

Public Version Number

3

DI Record Publish Date

May 19, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NEOTECH PRODUCTS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 153
2 A medical device with a moderate to high risk that requires special controls. 27