Identity
- Trade Name
- PressureMate Compression Assist Device FDA UDI
- Generic Name
- Femoral artery compression system, manual, reusable FDA UDI
- Device Name
- The PressureMate Compression Assist Device is designed to enhance comfort for the practitioner and the patient when applying external compression of the femoral artery. Practitioners apply external pressure with PressureMate in much the same way that they would when applying manual pressure. PressureMate is comprised of a non-sterile, reusable handle and a sterile, disposable SuperComfort Disc (Model 5303 or 5305) to aid in the practice of manual compression. The Model 3200 is of 12 oz. weighted aluminum construction. FDA UDI
- Model / Reference
- 3200 FDA UDI
- Description
- The PressureMate Compression Assist Device is designed to enhance comfort for the practitioner and the patient when applying external compression of the femoral artery. Practitioners apply external pressure with PressureMate in much the same way that they would when applying manual pressure. PressureMate is comprised of a non-sterile, reusable handle and a sterile, disposable SuperComfort Disc (Model 5303 or 5305) to aid in the practice of manual compression. The Model 3200 is of 12 oz. weighted aluminum construction. FDA UDI
Identifiers
- Catalog Number
- 130-0200-00 FDA UDI
- Primary DI / UDI-DI
- 10815614020057 FDA UDI
- 510(k) Number
- K090286 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
PressureMate Compression Assist Device by Semler Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K090286 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Semler Technologies, Inc.
Sources (1)
- FDA UDI 590baf4c-179e-4dd2-b223-72e5018da2fe 36 fields · synced Jun 1, 2026