Duns Number:080935429
Device Description: Monoject™ 0.9% Sodium Chloride Prefilled Flush Syringe, 10ML Fill, 12ML Syringe
Catalog Number
8881570121D
Brand Name
Monoject
Version/Model Number
8881570121D
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 01, 2021
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
1b8ee1d2-1d36-41df-88f3-b45d867fe194
Public Version Date
February 01, 2021
Public Version Number
3
DI Record Publish Date
September 26, 2019
Package DI Number
30884521750177
Quantity per Package
6
Contains DI Package
20884521750170
Package Discontinue Date
February 01, 2021
Package Status
Not 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 | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |