Duns Number:080935429
Device Description: 0.9% Sodium Chloride,Flush Syringe, 5 mL Fill
Catalog Number
8881579125
Brand Name
Monoject
Version/Model Number
8881579125
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 18, 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
17c071bc-2141-4f6f-aa6a-4fd15e1c7c8b
Public Version Date
February 19, 2021
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
10884521163690
Quantity per Package
100
Contains DI Package
30884521163694
Package Discontinue Date
February 18, 2021
Package Status
Not in Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| 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 |