Duns Number:926684994
Device Description: A1000 Single Use Syringe Kit, p/n 801060-003Kit Contents: 100mL contrast reservoir and tub A1000 Single Use Syringe Kit, p/n 801060-003Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp.
Catalog Number
-
Brand Name
A1000 Single Use Syringe Kit
Version/Model Number
016606
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K191060,K191060
Product Code
DXT
Product Code Name
Injector And Syringe, Angiographic
Public Device Record Key
685523a5-ebf1-4bdf-8dbf-72f3099ffe07
Public Version Date
April 20, 2020
Public Version Number
2
DI Record Publish Date
October 09, 2019
Package DI Number
30841716102159
Quantity per Package
10
Contains DI Package
10841716102155
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 193 |