Duns Number:079636164
Catalog Number
-
Brand Name
Dispenser, Liquid Medication
Version/Model Number
UA15-415-10-BOT-15BRW
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
aa49cb94-39c6-4f31-a2a6-68c0b18726d9
Public Version Date
December 31, 2020
Public Version Number
1
DI Record Publish Date
December 23, 2020
Package DI Number
10816513024573
Quantity per Package
10
Contains DI Package
00816513024576
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BAG
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 148 |