Duns Number:926684994
Device Description: Model BT2000 p/n 701671-002Kit Contents: manifold with saline and contrast ports, saline t Model BT2000 p/n 701671-002Kit Contents: manifold with saline and contrast ports, saline tubing with spike and hand syringe, transducer
Catalog Number
-
Brand Name
BT2000 Automated Manifold Kit
Version/Model Number
014613
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K171646,K171646
Product Code
DXT
Product Code Name
Injector And Syringe, Angiographic
Public Device Record Key
33bba1ec-5b5e-4b40-b824-d241670b5cc7
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
November 06, 2020
Package DI Number
30841716101565
Quantity per Package
10
Contains DI Package
10841716101561
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelf Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 193 |