Duns Number:042075700
Device Description: The Cordis Zephyr Vascular Compression Band Model 190101 has a single inflatable compressi The Cordis Zephyr Vascular Compression Band Model 190101 has a single inflatable compression balloon that is easily adjustable to help facilitate patent hemostasis in the radial artery. The Model 190101 provides a strap which is approximately 9.8" (25 cm) long.
Catalog Number
-
Brand Name
Cordis Zephyr Vascular Compression Band
Version/Model Number
190101
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
f25ebb06-1859-4978-9bd5-4244629150e5
Public Version Date
November 09, 2021
Public Version Number
1
DI Record Publish Date
November 01, 2021
Package DI Number
20815614020863
Quantity per Package
5
Contains DI Package
10815614020866
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |