Identity
- Trade Name
- ExpressAR Mobile Compression Device FDA UDI
- Generic Name
- Femoral artery compression system, manual, reusable FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 6225 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 160-2025-00 FDA UDI
- Primary DI / UDI-DI
- 10815614020644 FDA UDI
- 510(k) Number
- K970027 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
- 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Femoral artery compression system, manual, reusable
ExpressAR Mobile Compression Device by Semler Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Femoral artery compression system, manual, reusable.
- EZ Hold — Tz Medical, Inc. · Class II
- CompressAR XTS Stand — Semler Technologies, Inc. · Class II
- CompressAR Universal 1400 Stand — Semler Technologies, Inc. · Class II
- ClampEase Vascular Compression Device — Semler Technologies, Inc. · Class II
- CompressAR StrongArm XL 3-Finger Jack Stand — Semler Technologies, Inc. · Class II
- CompressAR StrongArm 3-FingerJack Stand — Semler Technologies, Inc. · Class II
- CompressAR StrongArm XL SuperComfort Stand — Semler Technologies, Inc. · Class II
- PressureMate Compression Assist Device — Semler Technologies, Inc. · Class II
Cleared under the same submission
K970027 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 7011074a-0492-4f0a-b340-665eb4b69e44 35 fields · synced Jun 8, 2026