Duns Number:080935429
Device Description: True content to be populated as part of rebranding
Catalog Number
8881570121
Brand Name
Monoject
Version/Model Number
8881570121
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 01, 2022
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"
-
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
NGT
Product Code Name
Saline, vascular access flush
Public Device Record Key
7b94fe8a-15b3-44ef-9c8f-501e6c251854
Public Version Date
February 11, 2022
Public Version Number
9
DI Record Publish Date
September 24, 2016
Package DI Number
20884521000268
Quantity per Package
30
Contains DI Package
10884521000261
Package Discontinue Date
February 01, 2022
Package Status
Not in Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |