Identity
- Trade Name
- CompressAR StrongArm XL SuperComfort Stand FDA UDI
- Generic Name
- Femoral artery compression system, manual, reusable FDA UDI
- Device Name
- The CompressAR StrongArm XL SuperComfort Stand is an extended length stand used with CompressAR SuperComfort Discs, to provide hemostasis of the femoral vascular access site following femoral artery catheterization procedures. FDA UDI
- Model / Reference
- 6000 FDA UDI
- Description
- The CompressAR StrongArm XL SuperComfort Stand is an extended length stand used with CompressAR SuperComfort Discs, to provide hemostasis of the femoral vascular access site following femoral artery catheterization procedures. FDA UDI
Identifiers
- Catalog Number
- 160-0000-17 FDA UDI
- Primary DI / UDI-DI
- 10815614020507 FDA UDI
- 510(k) Number
- K040615 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
CompressAR StrongArm XL SuperComfort Stand 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
K040615 also covers:
- CompressAR Jumbo SuperComfort Disc — Semler Technologies, Inc.
- CompressAR Large SuperComfort Disc — Semler Technologies, Inc.
- CompressAR StrongArm SuperComfort Stand — Semler Technologies, Inc.
- CompressAR StrongArm XL SuperComfort Stand — Semler Technologies, Inc.
- CompressAR StrongArm XL SuperComfort Stand — Semler Technologies, Inc.
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 85760243-2c16-4958-bdf3-a8d93762bd8a 35 fields · synced Jun 1, 2026