Identity
- Trade Name
- CompressAR Jumbo Comfort Disc FDA UDI
- Generic Name
- Femoral artery compression system, manual, single-use FDA UDI
- Device Name
- The CompressAR Jumbo 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 5207 is a jumbo sized round disc with upturned edges (2.625" dia.). FDA UDI
- Model / Reference
- 5207 FDA UDI
- Description
- The CompressAR Jumbo 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 5207 is a jumbo sized round disc with upturned edges (2.625" dia.). FDA UDI
Identifiers
- Catalog Number
- 150-0207-06 FDA UDI
- Primary DI / UDI-DI
- 10815614020217 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 Jumbo Comfort Disc by Semler Technologies, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 bfe3a891-5c30-4f9c-9ac8-cf3f2f44320e 35 fields · synced May 31, 2026