Duns Number:141668116
Device Description: Silicone Suction Tubing Connector 18 grams 6in in length 2.65mm wall thickness; OD 13.3m
Catalog Number
RES024L
Brand Name
Sunset Healthcare Solutions Silicone Suction Tubing Connector - 6in
Version/Model Number
RES024L
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GAZ
Product Code Name
Tubing, Noninvasive
Public Device Record Key
9c835f24-5b83-495a-955c-a609177d3eb7
Public Version Date
June 08, 2021
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
20848530061344
Quantity per Package
10
Contains DI Package
10848530061347
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Corrugated Box
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 |