Identity
- Trade Name
- CompressAR Universal 1400 Stand FDA UDI
- Generic Name
- Femoral artery compression system, manual, reusable FDA UDI
- Device Name
- The CompressAR Universal 1400 Stand is an extended length stand with a base plate for use with a Hill-Rom VersaCare® bed and is used with CompressAR discs to provide hemostasis of the femoral artery vascular access site following femoral artery catheterization procedures. FDA UDI
- Model / Reference
- 1400 FDA UDI
- Description
- The CompressAR Universal 1400 Stand is an extended length stand with a base plate for use with a Hill-Rom VersaCare® bed and is used with CompressAR discs to provide hemostasis of the femoral artery vascular access site following femoral artery catheterization procedures. FDA UDI
Identifiers
- Catalog Number
- 160-0004-00 FDA UDI
- Primary DI / UDI-DI
- 10815614020545 FDA UDI
- 510(k) Number
- K925809 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 Universal 1400 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
- 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
- CompressAR StrongArm XL SuperComfort Stand — Semler Technologies, Inc. · Class II
Cleared under the same submission
K925809 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 |
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Manufacturer
- Manufacturer
- Semler Technologies, Inc.
Sources (1)
- FDA UDI c3e31bb5-7e1f-4694-bd2b-ac7ef8dfbcb9 35 fields · synced May 30, 2026