Duns Number:091301184
Device Description: One set contains:1 - Branched line with two male luer-lock fittings on the distal end and One set contains:1 - Branched line with two male luer-lock fittings on the distal end and one luer-lock female fitting with a luer activated valve on the proximal end. Length: 96 inches.1 - Straight gas line, whit one male luer-lock fitting on the distal end and one luer-lock female fitting with a luer activated valve on the proximal end. Length: 96 inches.
Catalog Number
-
Brand Name
Kronner Side-Kick High Pressure Gas Line Set
Version/Model Number
HPL1-BL1-V2
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"
-
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
K130758,K130758
Product Code
LKF
Product Code Name
Cannula, Manipulator/Injector, Uterine
Public Device Record Key
8c353153-5295-4c8a-9baf-3bee5ac7f27c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 26, 2017
Package DI Number
00856589007080
Quantity per Package
25
Contains DI Package
00856589007073
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |