Portable Suction Machine Replacement Power Adapter (without Cord) - Portable Suction Machine. Replacement Power - SUNSET HEALTHCARE SOLUTIONS, INC.

Duns Number:141668116

Device Description: Portable Suction Machine. Replacement Power Adapter (without Cord)

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More Product Details

Catalog Number

SU100DC-Adapt

Brand Name

Portable Suction Machine Replacement Power Adapter (without Cord)

Version/Model Number

SU100DC-Adapt

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

GCX

Product Code Name

Apparatus, Suction, Operating-Room, Wall Vacuum Powered

Device Record Status

Public Device Record Key

d39cb167-ccd3-4cca-a1e2-3c1f61e55338

Public Version Date

January 08, 2021

Public Version Number

4

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