Duns Number:042075700
Device Description: The Zephyr Vascular Compression Device Model 9100-20 has a single easily inflatable compre The Zephyr Vascular Compression Device Model 9100-20 has a single easily inflatable compression balloon that is easily adjustable to help facilitate patent hemostasis in the radial artery. The Model 9100-20 provides the large strap which 11.8”/30cm long.
Catalog Number
190-0100-20
Brand Name
Zephyr Vascular Compression Device
Version/Model Number
9100-20
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
K151363,K151363,K151363
Product Code
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
71719972-e597-4a26-a70f-4978845972fb
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 17, 2017
Package DI Number
30815614020747
Quantity per Package
10
Contains DI Package
10815614020743
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 1 |