Duns Number:799772079
Device Description: NeoBottle Oral Dispenser, Sterile, Amber, 80 mL
Catalog Number
SSNB-AM
Brand Name
NeoBottle
Version/Model Number
SSNB-AM
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
fdd5b673-9ac2-4905-83e6-e017b136abf3
Public Version Date
October 29, 2021
Public Version Number
6
DI Record Publish Date
September 19, 2016
Package DI Number
10817584010236
Quantity per Package
60
Contains DI Package
00817584010239
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 |