Duns Number:023904428
Device Description: Normal Saline IV Flush Syringe; 10 ml fill in 12ml Syringe
Catalog Number
-
Brand Name
McKesson
Version/Model Number
191-MIS-1130
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
K091583,K091583,K091583
Product Code
NGT
Product Code Name
Saline, Vascular Access Flush
Public Device Record Key
0acb741d-65b8-45ba-ae78-140dd2098a3b
Public Version Date
October 14, 2019
Public Version Number
1
DI Record Publish Date
October 04, 2019
Package DI Number
40612479247695
Quantity per Package
16
Contains DI Package
20612479247684
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 | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |