Duns Number:825673239
Device Description: AMSafe® Pre-Filled Normal Saline Flush Syringe0.9% Sodium Chloride Injection, USPSterile F AMSafe® Pre-Filled Normal Saline Flush Syringe0.9% Sodium Chloride Injection, USPSterile Fluid & PathDo Not Place Syringe on a Sterile Field20 mL Fill • Preservative Free
Catalog Number
IVF2020
Brand Name
AMSafe® Pre-Filled Normal Saline Flush Syringe
Version/Model Number
1
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
K183473,K183473,K183473
Product Code
NGT
Product Code Name
Saline, Vascular Access Flush
Public Device Record Key
40e7bbc9-af09-4a1b-9653-8ffed9c498b9
Public Version Date
September 09, 2022
Public Version Number
2
DI Record Publish Date
February 10, 2020
Package DI Number
30704411009966
Quantity per Package
30
Contains DI Package
00704411009965
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |