Identity
- Trade Name
- CompressAR Large SuperComfort Disc FDA UDI
- Generic Name
- Femoral artery compression system, manual, single-use FDA UDI
- Device Name
- The CompressAR Large SuperComfort 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 5303 is a large sized round disc with upturned edges and an elastomeric center (2" dia.). FDA UDI
- Model / Reference
- 5303 FDA UDI
- Description
- The CompressAR Large SuperComfort 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 5303 is a large sized round disc with upturned edges and an elastomeric center (2" dia.). FDA UDI
Identifiers
- Catalog Number
- 150-0303-06 FDA UDI
- Primary DI / UDI-DI
- 10815614020231 FDA UDI
- 510(k) Number
- K040615 FDA UDI
- FDA Product Code
- DXC FDA UDI
- GMDN Term
- Femoral artery compression system, manual, single-use 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
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 SuperComfort Disc 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, single-use.
- SAFEGUARD® — Merit Medical Systems, Inc. · Class II
- TZ Medical Pressure Discs — Tz Medical, Inc. · Class II
- SAFEGUARD® — Merit Medical Systems, Inc. · Class II
- SAFEGUARD™ — Merit Medical Systems, Inc. · Class II
- SAFEGUARD™ — Merit Medical Systems, Inc. · Class II
- TZ Medical Pressure Discs — Tz Medical, Inc. · Class II
- TZ Medical Pressure Discs — Tz Medical, Inc. · Class II
- TZ Medical Pressure Discs — Tz Medical, Inc. · Class II
Cleared under the same submission
K040615 also covers:
- CompressAR Jumbo 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.
- 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 02fa85ab-45fb-433c-a70a-23a77c17fe8a 35 fields · synced May 30, 2026