Duns Number:013112308
Device Description: I.V. CATHETER PEN TYPE 20 G X 1 1/4 100 EA.
Catalog Number
-
Brand Name
Rospital Productos Medicos
Version/Model Number
IVCT20
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
K142797,K142797,K142797
Product Code
FOZ
Product Code Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Public Device Record Key
46d4f7bf-34df-4c2a-b1e2-5e1e84ed1c2d
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
April 02, 2021
Package DI Number
10812460028619
Quantity per Package
100
Contains DI Package
00812460028612
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
INNER BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 17 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |