Duns Number:141668116
Device Description: Silicone Suction Tubing Connector. 1.5in Length, 2.65mm Wall Thickness, 13.3mm OD
Catalog Number
RES024S
Brand Name
Silicone Suction Tubing Connector
Version/Model Number
RES024S
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
-
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
BZD
Product Code Name
Ventilator, Non-Continuous (Respirator)
Public Device Record Key
9151eec5-4c9d-4862-a36c-c518630f351d
Public Version Date
June 29, 2018
Public Version Number
1
DI Record Publish Date
May 29, 2018
Package DI Number
01084853008795
Quantity per Package
10
Contains DI Package
00848530087951
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |