Duns Number:005083209
Device Description: Oral Dispenser Clear 5 mL Pharmacy Pack
Catalog Number
H9387105
Brand Name
EXACTAMED
Version/Model Number
H9387105
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
-
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
810693fe-d2da-4f67-99ce-db8b98ad5b99
Public Version Date
October 29, 2021
Public Version Number
2
DI Record Publish Date
September 24, 2020
Package DI Number
50085412478024
Quantity per Package
100
Contains DI Package
00085412478029
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 |