Carry Bag for Portable Suction Machine - Carry Bag for Portable Suction Machine - SUNSET HEALTHCARE SOLUTIONS, INC.

Duns Number:141668116

Device Description: Carry Bag for Portable Suction Machine

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More Product Details

Catalog Number

SU100DC-BAG

Brand Name

Carry Bag for Portable Suction Machine

Version/Model Number

SU100DC-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

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

44f822c6-92e5-4332-9898-a9887e8f0ca2

Public Version Date

April 21, 2021

Public Version Number

5

DI Record Publish Date

May 25, 2018

Additional Identifiers

Package DI Number

10848530089211

Quantity per Package

4

Contains DI Package

00848530089214

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