Duns Number:825673239
Device Description: Pre-Filled Normal Saline Flush Syringe, 5 ml 0.9% Sodium Chloride Injection, USP, poly bl Pre-Filled Normal Saline Flush Syringe, 5 ml 0.9% Sodium Chloride Injection, USP, poly blister package, Sterile Field Ready, Gamma radiation sterilization
Catalog Number
IVF1005SS
Brand Name
AMSafe ® Pre-Filled Normal Saline Flush Syringe
Version/Model Number
1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 05, 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"
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
K183473,K183473
Product Code
NGT
Product Code Name
Saline, Vascular Access Flush
Public Device Record Key
880e0bc6-c8f9-475d-8fc4-fe6c8f69af56
Public Version Date
October 13, 2022
Public Version Number
1
DI Record Publish Date
October 05, 2022
Package DI Number
40704411013519
Quantity per Package
180
Contains DI Package
30704411013512
Package Discontinue Date
October 05, 2022
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 | 89 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 411 |
| U | Unclassified | 1 |