Full Face CPAP Mask — Medium - Includes 1 medium sized mask, with headgear and - SUNSET HEALTHCARE SOLUTIONS, INC.

Duns Number:141668116

Device Description: Includes 1 medium sized mask, with headgear and replaceable cushion.

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More Product Details

Catalog Number

CM005MPL

Brand Name

Full Face CPAP Mask — Medium

Version/Model Number

CM005MPL

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)

-

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

BZD

Product Code Name

Ventilator, Non-Continuous (Respirator)

Device Record Status

Public Device Record Key

03d3c572-204f-4526-a9c7-6fbd4c1732c5

Public Version Date

August 31, 2018

Public Version Number

1

DI Record Publish Date

July 31, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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