Duns Number:787026855
Device Description: Safe, easy, and accurate way to dispense liquid medicineMedicine bypasses baby's taste bud Safe, easy, and accurate way to dispense liquid medicineMedicine bypasses baby's taste buds reducing gagging and spitting up
Catalog Number
-
Brand Name
The Medicator
Version/Model Number
12501
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"
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For Single-Use
-
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
KYW
Product Code Name
Container, Liquid Medication, Graduated
Public Device Record Key
62cbbb27-bca7-4ad4-90c3-0a2bf3539aca
Public Version Date
October 06, 2021
Public Version Number
2
DI Record Publish Date
February 12, 2019
Package DI Number
10735282125017
Quantity per Package
36
Contains DI Package
00735282125010
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 | 4 |
2 | A medical device with a moderate to high risk that requires special controls. | 4 |