Identity
- Trade Name
- CompressAR Elliptical Comfort Disc FDA UDI
- Generic Name
- Femoral artery compression system, manual, single-use FDA UDI
- Device Name
- The CompressAR Oval (Elliptical) Comfort 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 5197 is an oval (ellliptical) disc with upturned edges (1.75” x 2.5"). FDA UDI
- Model / Reference
- 5197 FDA UDI
- Description
- The CompressAR Oval (Elliptical) Comfort 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 5197 is an oval (ellliptical) disc with upturned edges (1.75” x 2.5"). FDA UDI
Identifiers
- Catalog Number
- 150-0197-06 FDA UDI
- Primary DI / UDI-DI
- 10815614020200 FDA UDI
- 510(k) Number
- K891000 FDA UDI
- FDA Product Code
- DWS FDA UDI
- GMDN Term
- Femoral artery compression system, manual, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.4500 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 Elliptical Comfort Disc by Semler Technologies, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Femoral artery compression system, manual, single-use.
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- SAFEGUARD™ — Merit Medical Systems, Inc. · Class II
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- TZ Medical Pressure Discs — Tz Medical, Inc. · Class II
- TZ Medical Pressure Discs — Tz Medical, Inc. · Class II
Cleared under the same submission
K891000 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 I | Pending data |
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Manufacturer
- Manufacturer
- Semler Technologies, Inc.
Sources (1)
- FDA UDI c1cb5fa9-3c61-42d2-be38-53ce1551cbe1 35 fields · synced May 31, 2026