Duns Number:005083209
Device Description: Tamper Resistant Add-Port Cap
Catalog Number
H9384858
Brand Name
EXACTAMIX
Version/Model Number
H9384858
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
KYX
Product Code Name
DISPENSER, LIQUID MEDICATION
Public Device Record Key
e0cd6fdd-72d6-41d0-b7f6-f56ef56a4060
Public Version Date
November 05, 2020
Public Version Number
2
DI Record Publish Date
April 08, 2019
Package DI Number
55413765477312
Quantity per Package
100
Contains DI Package
05413765477317
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |
| 3 | A medical device with high risk that requires premarket approval | 19 |