Catalog Number
HCT8874VA-V
Brand Name
HCT
Version/Model Number
HCT8874VA-V
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
-
Product Code
OWL
Product Code Name
Peripheral catheter insertion kit
Public Device Record Key
54001b74-6fdf-4485-9e8c-8a8217b8af4a
Public Version Date
June 07, 2019
Public Version Number
3
DI Record Publish Date
September 20, 2016
Package DI Number
38498840009988
Quantity per Package
20
Contains DI Package
08498840009987
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 | 124 |
2 | A medical device with a moderate to high risk that requires special controls. | 833 |