Identity
- Trade Name
- FMS VUE FDA UDI
- Generic Name
- Arthroscopic irrigation/insufflation system FDA UDI
- Device Name
- FMS VUE Fluid Management System FDA UDI
- Model / Reference
- 284002 FDA UDI
- Description
- FMS VUE Fluid Management System FDA UDI
Identifiers
- Catalog Number
- 284002 FDA UDI
- Primary DI / UDI-DI
- 10886705020591 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Arthroscopic irrigation/insufflation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Arthroscopic irrigation/insufflation system
Fms Vue by DePuy Mitek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Arthroscopic irrigation/insufflation system.
- Arthrex® — Arthrex, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class II
- FMS VUE II — Medos International Sàrl · Class II
- GoFlo Pump — W.O.M. World of Medicine GmbH · Class II
- SHAVER INTERFACE — Biomet Orthopedics, Inc. · Class I
- Coblation — Smith & Nephew, Inc. · Class II
- Arthrex® — Arthrex, Inc. · Class I
- GoFlo Pump — W.O.M. World of Medicine GmbH · Class II
Cleared under the same submission
K130169 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 II | Pending data |
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Manufacturer
- Manufacturer
- DePuy Mitek, Inc.
Sources (1)
- FDA UDI 700c40e0-5c8e-4b27-a5a7-baf0a6c3552b 37 fields · synced May 30, 2026