Duns Number:799772079
Device Description: Sterile Oral Syringe, 6mL
Catalog Number
BA-S6EO-S
Brand Name
NeoMed Oral Syringe
Version/Model Number
BA-S6EO-S
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
818f957b-aed1-4832-bd33-a5af83715984
Public Version Date
October 29, 2021
Public Version Number
6
DI Record Publish Date
September 19, 2016
Package DI Number
10817584010168
Quantity per Package
200
Contains DI Package
00817584010161
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 | 23 |
2 | A medical device with a moderate to high risk that requires special controls. | 183 |