Identity
- Trade Name
- CompressAR Large Round Disc FDA UDI
- Generic Name
- Femoral artery compression system, manual, single-use FDA UDI
- Device Name
- The CompressAR Large Round Disc is a sterile, single use product that is attached to the CompressAR System Stand to apply compression to the femoral artery during hemostasis. The Model 5123 is a large, round flat disc (2" dia.). FDA UDI
- Model / Reference
- 5123 FDA UDI
- Description
- The CompressAR Large Round Disc is a sterile, single use product that is attached to the CompressAR System Stand to apply compression to the femoral artery during hemostasis. The Model 5123 is a large, round flat disc (2" dia.). FDA UDI
Identifiers
- Catalog Number
- 150-0123-06 FDA UDI
- Primary DI / UDI-DI
- 10815614020187 FDA UDI
- 510(k) Number
- K831337 FDA UDI
- FDA Product Code
- DQO FDA UDI
- GMDN Term
- Femoral artery compression system, manual, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Femoral artery compression system, manual, single-use
CompressAR Large Round Disc by Semler Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 06ebd276-c5f5-45a2-ad87-ffed22c72a28 35 fields · synced May 30, 2026