Duns Number:053469565
Device Description: "For use on the medication port of ICU Medical LifeCare ® to provide both visual evidence "For use on the medication port of ICU Medical LifeCare ® to provide both visual evidence that medication has been added and tamper evidence once the device is closed.Packaged in Non-Sterile Bags of 50, 2 bags per shipper box"
Catalog Number
21-03-100
Brand Name
Tamper Evident Additive Port Cap
Version/Model Number
21-03-100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K190305,K190305,K190305
Product Code
KPE
Product Code Name
Container, I.V.
Public Device Record Key
b3597b8f-8ffa-48f0-9a87-9ea2084a70df
Public Version Date
October 18, 2022
Public Version Number
1
DI Record Publish Date
October 10, 2022
Package DI Number
B21221031002
Quantity per Package
2
Contains DI Package
B21221031001
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |