Duns Number:444776777
Device Description: I.V. Catheter with protector
Catalog Number
-
Brand Name
SOL CARE T
Version/Model Number
SIV008
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
1f48dbcd-a1d3-4ec7-be29-654008fc56a2
Public Version Date
April 07, 2021
Public Version Number
1
DI Record Publish Date
March 30, 2021
Package DI Number
38032248007193
Quantity per Package
50
Contains DI Package
08032248007192
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 105 |