Duns Number:042075700
Device Description: The Zephyr Vascular Compression Device Model 9100-10 has a single easily inflatable compre
Catalog Number
190-0100-10
Brand Name
Zephyr Vascular Compression Device
Version/Model Number
9100-10
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 28, 2020
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
9ce4228d-8b69-46e8-9b2c-d5a4ead67b67
Public Version Date
September 29, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
20815614020382
Quantity per Package
50
Contains DI Package
10815614020385
Package Discontinue Date
September 28, 2020
Package Status
Not 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 1 |