Identity
- Trade Name
- RadAR EasyClik Vascular Compression Device FDA UDI
- Generic Name
- Radial artery compression device FDA UDI
- Device Name
- The RadAR EasyClik Vascular Compression Device Model 4195 provides economical, safe hemostasis for your post-catheterization radial access patients. The user can quickly make compression adjustments to permit patient blood flow through the artery and gradually release pressure during hemostasis, without unfastening the device. This enables patient hemostasis which has been shown to reduce the incidence of chronic radial artery occlusion. The Model 4195 is natural in color. FDA UDI
- Model / Reference
- 4195 FDA UDI
- Description
- The RadAR EasyClik Vascular Compression Device Model 4195 provides economical, safe hemostasis for your post-catheterization radial access patients. The user can quickly make compression adjustments to permit patient blood flow through the artery and gradually release pressure during hemostasis, without unfastening the device. This enables patient hemostasis which has been shown to reduce the incidence of chronic radial artery occlusion. The Model 4195 is natural in color. FDA UDI
Identifiers
- Catalog Number
- 140-0195-00 FDA UDI
- Primary DI / UDI-DI
- 10815614020842 FDA UDI
- 510(k) Number
- K092503 FDA UDI
- FDA Product Code
- DXC FDA UDI
- GMDN Term
- Radial artery compression device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4450 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radial artery compression device
RadAR EasyClik Vascular Compression Device by Semler Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Radial artery compression device.
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- TRAcelet™ — MEDTRONIC, INC. · Class II
- PreludeSYNC DISTAL™ — Merit Medical Systems, Inc. · Class II
- PreludeSYNC EVO™ — Merit Medical Systems, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Semler Technologies, Inc.
Sources (1)
- FDA UDI 31b9e8fd-015b-4186-957e-f390e52d4cac 35 fields · synced Jun 8, 2026