Identity
- Trade Name
- Zephyr Vascular Compression Device FDA UDI
- Generic Name
- Radial artery compression device FDA UDI
- Device Name
- The Zephyr Vascular Compression Device Model 9100-00 has a single easily inflatable compression balloon that is easily adjustable to help facilitate patent hemostasis in the radial artery. The Model 9100-00 provides the small sized strap which is 8.2”/21cm long. FDA UDI
- Model / Reference
- 9100-00 FDA UDI
- Description
- The Zephyr Vascular Compression Device Model 9100-00 has a single easily inflatable compression balloon that is easily adjustable to help facilitate patent hemostasis in the radial artery. The Model 9100-00 provides the small sized strap which is 8.2”/21cm long. FDA UDI
Identifiers
- Catalog Number
- 190-0100-00 FDA UDI
- Primary DI / UDI-DI
- 10815614020378 FDA UDI
- 510(k) Number
- K151363 FDA UDI
- FDA Product Code
- DXC FDA UDI
- GMDN Term
- Radial artery compression device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4450 FDA UDI
- Commercial Distribution
- Not 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
Zephyr Vascular Compression Device by Semler Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Semler Technologies, Inc.
Sources (1)
- FDA UDI e8052e61-d003-4076-969b-c901098b1cef 36 fields · synced May 30, 2026