Identity
- Trade Name
- XMI FDA UDI
- Generic Name
- Thrombectomy suction catheter FDA UDI
- Device Name
- XMI CUS CATHETER, FG PKG FDA UDI
- Model / Reference
- 105041-001 FDA UDI
- Description
- XMI CUS CATHETER, FG PKG FDA UDI
Identifiers
- Catalog Number
- 105041 FDA UDI
- Primary DI / UDI-DI
- 00616258003894 FDA UDI
- FDA Product Code
- DXE FDA UDI
- GMDN Term
- Thrombectomy suction catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5150 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 4 French FDA UDI
Category: Thrombectomy suction catheter
Xmi by Bayer Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thrombectomy suction catheter.
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- Penumbra System — PENUMBRA, INC. · Class II
- Trevo — Stryker Corp.
- Penumbra System — PENUMBRA, INC. · Class II
- Pounce ™ Thrombectomy — Surmodics, Inc. · Class II
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
- Bayer Healthcare
Sources (1)
- FDA UDI 6b6d45a8-eddf-4b9b-8ceb-4bb289660140 36 fields · synced May 30, 2026