Sunset Healthcare Solutions 800cc Suction Canister - 1/Case - Sunset Healthcare Solutions 800cc Suction - SUNSET HEALTHCARE SOLUTIONS, INC.

Duns Number:141668116

Device Description: Sunset Healthcare Solutions 800cc Suction Canister - 1/Case

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More Product Details

Catalog Number

RES023-1

Brand Name

Sunset Healthcare Solutions 800cc Suction Canister - 1/Case

Version/Model Number

RES023-1

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

d5c5164c-742a-4375-81a7-6e087726c754

Public Version Date

January 08, 2021

Public Version Number

7

DI Record Publish Date

September 23, 2016

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