Duns Number:013112308
Device Description: I.V. CATHETER PEN TYPE 22 G X 1 100 EA.
Catalog Number
IVTC22
Brand Name
Rospital Productos Medicos
Version/Model Number
IVTC22
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)
-
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
bd43eba2-287f-4415-8779-6f443229cc8f
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
April 02, 2021
Package DI Number
10812460028626
Quantity per Package
100
Contains DI Package
00812460028629
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 |