Duns Number:259901445
Device Description: 5 mL of 0.9% Sodium Chloride Injection USP in a 5 mL syringe
Catalog Number
3704US
Brand Name
Praxiject™ 0.9% NaCl
Version/Model Number
3704US
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
K171109,K171109,K171109
Product Code
NGT
Product Code Name
Saline, Vascular Access Flush
Public Device Record Key
36f9b5a8-29cb-4d72-bb41-99dc5d5755cd
Public Version Date
July 09, 2020
Public Version Number
3
DI Record Publish Date
March 19, 2018
Package DI Number
20682686004479
Quantity per Package
120
Contains DI Package
10682686004472
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 5 |