Duns Number:444776777
Device Description: Safety I.V Catheter in PUR with closed system , Y final adapter and detachable needless va Safety I.V Catheter in PUR with closed system , Y final adapter and detachable needless valve
Catalog Number
-
Brand Name
DELTAVEN
Version/Model Number
3841172
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FOZ
Product Code Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Public Device Record Key
bc45d25b-4be0-4418-8840-b5131ff1d18c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 19, 2018
Package DI Number
58032248384113
Quantity per Package
4
Contains DI Package
38032248384119
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 105 |