Duns Number:080935429
Device Description: 0.9% Sodium Chloride,Flush Syringe, 10 mL Fill, Sterile Delivery
Catalog Number
8881570128
Brand Name
Monoject
Version/Model Number
8881570128
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 28, 2020
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
a94c3df3-69fc-45fc-8e32-be3a0c4278c3
Public Version Date
October 06, 2020
Public Version Number
8
DI Record Publish Date
September 24, 2016
Package DI Number
20884521163024
Quantity per Package
20
Contains DI Package
10884521163027
Package Discontinue Date
April 28, 2020
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 |