Duns Number:042075700
Device Description: The ComfortPress Hand-Held Vascular Compression Assist Device is an ergonomic, sterile, di The ComfortPress Hand-Held Vascular Compression Assist Device is an ergonomic, sterile, disposable external compression device. ComfortPress is designed to enhance comfort for the practitioner and the patient when applying external compression of the femoral artery. Practitioners apply external pressure using ComfortPress in much the same way that they would when applying manual pressure. The Model 3100-05 is a large sterile molded handle fitted with a Jumbo SuperComfort™ Disc in a sealed package. This is a single use device.
Catalog Number
130-0100-05
Brand Name
ComfortPress Hand-Held Vascular Compression Assist Device
Version/Model Number
3100-05
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
K072167,K072167
Product Code
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
9c6030b9-1611-4c98-9feb-c922f3fbcd79
Public Version Date
November 22, 2018
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
20815614020023
Quantity per Package
20
Contains DI Package
10815614020026
Package Discontinue Date
-
Package Status
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 |