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CompressAR Compass Hand-Held Vascular Compression Assist Device
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- CompressAR Compass Hand-Held Vascular Compression Assist Device FDA UDI
- Generic Name
- Femoral artery compression system, manual, reusable FDA UDI
- Device Name
- The CompressAR Compass Hand-Held Compression Assist Device is a hand-held external compression device designed to enhance comfort for the practitioner and the patient when applying external compression of the femoral artery. Practitioners apply external pressure using Compass in much the same way that they would when applying manual pressure. The CompressAR Compass Hand-Held Compression Assist Device is comprised of a non-sterile handle for use with disposable, sterile SuperComfort compression discs (Model 5303 or 5305). FDA UDI
- Model / Reference
- 3000 FDA UDI
- Description
- The CompressAR Compass Hand-Held Compression Assist Device is a hand-held external compression device designed to enhance comfort for the practitioner and the patient when applying external compression of the femoral artery. Practitioners apply external pressure using Compass in much the same way that they would when applying manual pressure. The CompressAR Compass Hand-Held Compression Assist Device is comprised of a non-sterile handle for use with disposable, sterile SuperComfort compression discs (Model 5303 or 5305). FDA UDI
Identifiers
- Catalog Number
- 130-0000-01 FDA UDI
- Primary DI / UDI-DI
- 10815614020002 FDA UDI
- 510(k) Number
- K053398 FDA UDI
- FDA Product Code
- DXC FDA UDI
- GMDN Term
- Femoral artery compression system, manual, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4450 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
CompressAR Compass Hand-Held Vascular Compression Assist Device by Semler Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID
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 77106e9c-fb6e-4b9a-955b-a9add6481420 36 fields · synced May 30, 2026