FMS VUE 284002
GUDID 10886705020591
FMS VUE Fluid Management System
DEPUY MITEK, LLC
Arthroscopic irrigation/insufflation system| Primary Device ID | 10886705020591 |
| NIH Device Record Key | 700c40e0-5c8e-4b27-a5a7-baf0a6c3552b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FMS VUE |
| Version Model Number | 284002 |
| Catalog Number | 284002 |
| Company DUNS | 190572854 |
| Company Name | DEPUY MITEK, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
Operating and Storage Conditions
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10886705020591 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K130169
FDA Product Code
| HRX | ARTHROSCOPE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-03-25 |
| Device Publish Date | 2015-09-01 |
Devices Manufactured by DEPUY MITEK, LLC
| 20886705011022 - STRAIGHTSHOT | 2024-08-20 STRAIGHTSHOT LIGAMENT GRAFT PASSER/PROTECTOR 8.5mm |
| 20886705011039 - STRAIGHTSHOT | 2024-08-20 STRAIGHTSHOT LIGAMENT GRAFT PASSER/PROTECTOR 9.5mm |
| 20886705011060 - NA | 2024-08-20 LIGAMENT GRAFT PASSER/PROTECTOR 7.5mm |
| 20886705011077 - NA | 2024-08-20 LIGAMENT GRAFT PASSER/PROTECTOR 8.5mm |
| 20886705011084 - NA | 2024-08-20 LIGAMENT GRAFT PASSER/PROTECTOR 9.5mm |
| 20886705011091 - NA | 2024-08-20 LIGAMENT GRAFT PASSER/PROTECTOR 10.5mm |
| 20886705011107 - NA | 2024-08-20 LIGAMENT GRAFT PASSER/PROTECTOR 11.5mm |
| 10886705012480 - COR | 2024-08-20 Mitek COR Plunger 4mm, 5-25mm (Plus or Minus 10 Percent) |
Trademark Results [FMS VUE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FMS VUE 85340228 4576230 Live/Registered |
FMS Future Medical System S.A. 2011-06-07 |
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