Sunset Homefill Tubing Connector - Coiled - Sunset Homefill Tubing Connector - Coiled - SUNSET HEALTHCARE SOLUTIONS, INC.

Duns Number:141668116

Device Description: Sunset Homefill Tubing Connector - Coiled

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More Product Details

Catalog Number

RES039

Brand Name

Sunset Homefill Tubing Connector - Coiled

Version/Model Number

RES039

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

BYX

Product Code Name

Tubing, Pressure And Accessories

Device Record Status

Public Device Record Key

6011e05b-e9a7-4d63-95cc-560ba99b971a

Public Version Date

July 04, 2022

Public Version Number

2

DI Record Publish Date

September 25, 2018

Additional Identifiers

Package DI Number

20848530084459

Quantity per Package

5

Contains DI Package

10848530084452

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