Duns Number:141668116
Device Description: 18" Suction Connecting Tube - 18" in Length - 1/4" Diameter
Catalog Number
RES025S
Brand Name
Sunset Healthcare Solutions Suction Tubing - 18"
Version/Model Number
RES025S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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"
Yes
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
JOL
Product Code Name
Catheter And Tip, Suction
Public Device Record Key
3bb9234b-b932-4b68-98f2-4faa6afca738
Public Version Date
June 08, 2021
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
10848530061583
Quantity per Package
50
Contains DI Package
00848530061586
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
corrugated boxes
| 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 |