Duns Number:001061233
Device Description: Dale IV, Arterial and Mid-line Catheter Securement Device
Catalog Number
850
Brand Name
Dale Catheter Securement Device
Version/Model Number
850
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KMK
Product Code Name
Device, Intravascular Catheter Securement
Public Device Record Key
80ea423d-ea79-44f9-817e-2a025f1e900d
Public Version Date
July 22, 2019
Public Version Number
3
DI Record Publish Date
September 10, 2018
Package DI Number
00817612020131
Quantity per Package
50
Contains DI Package
00817612020124
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 74 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |