Duns Number:555472310
Catalog Number
400150
Brand Name
SecurAcath
Version/Model Number
6F
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
KMK
Product Code Name
Device, Intravascular Catheter Securement
Public Device Record Key
8612509b-7550-4b20-beba-896f23390caa
Public Version Date
June 04, 2020
Public Version Number
6
DI Record Publish Date
September 15, 2016
Package DI Number
10865382000232
Quantity per Package
10
Contains DI Package
00865382000235
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelf Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 6 |