DeVilbiss - Compressor / Nebulizer with disposable - Private - DEVILBISS HEALTHCARE LLC

Duns Number:962175894

Device Description: Compressor / Nebulizer with disposable - Private Label Theda Care at Home

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More Product Details

Catalog Number

3655LTPL-THED

Brand Name

DeVilbiss

Version/Model Number

3655LTPL-THED

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

-

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

K020932,K020932

Product Code Details

Product Code

BTI

Product Code Name

Compressor, Air, Portable

Device Record Status

Public Device Record Key

e69183d0-03e7-44af-99d7-cf03fc797626

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 21, 2017

Additional Identifiers

Package DI Number

10885304001048

Quantity per Package

6

Contains DI Package

00885304001041

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"DEVILBISS HEALTHCARE LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 197