Bag for Compressor Nebulizer - Bag for Compressor Nebulizer - SUNSET HEALTHCARE SOLUTIONS, INC.

Duns Number:141668116

Device Description: Bag for Compressor Nebulizer

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More Product Details

Catalog Number

NEB100-BAG

Brand Name

Bag for Compressor Nebulizer

Version/Model Number

NEB100-BAG

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)

-

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

CCX

Product Code Name

Support, Patient Position

Device Record Status

Public Device Record Key

bbbb95e2-5f2c-4e55-bf78-c879ed7d4aa5

Public Version Date

April 21, 2021

Public Version Number

5

DI Record Publish Date

May 29, 2018

Additional Identifiers

Package DI Number

10848530087965

Quantity per Package

50

Contains DI Package

00848530087968

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"SUNSET HEALTHCARE SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 160
2 A medical device with a moderate to high risk that requires special controls. 68