Duns Number:025460908
Device Description: Heparin Lock Flush, USP
Catalog Number
513602
Brand Name
Excelsior
Version/Model Number
50051
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
K133446,K133446,K133446
Product Code
NZW
Product Code Name
Heparin, vascular access flush
Public Device Record Key
50159934-e43f-49a1-b700-91e418b43a73
Public Version Date
July 07, 2020
Public Version Number
5
DI Record Publish Date
September 19, 2016
Package DI Number
10363807500058
Quantity per Package
10
Contains DI Package
00363807500051
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |