Duns Number:042075700
Device Description: The ExpressAR Mobile Compression Device is a durable, reusable precision instrument that c The ExpressAR Mobile Compression Device is a durable, reusable precision instrument that can be cleaned for reuse. When deploying ExpressAR, a sterile, disposable Disc and a non-sterile disposable Belt are attached to the device. The Disc and Belt come packaged as an ExpressAR Belt Kit, available with different sizes of Discs.
Catalog Number
160-2025-00
Brand Name
ExpressAR Mobile Compression Device
Version/Model Number
6225
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
-
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
K970027
Product Code
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
7011074a-0492-4f0a-b340-665eb4b69e44
Public Version Date
October 05, 2018
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |