FMS VUE 284002

GUDID 10886705020591

FMS VUE Fluid Management System

DEPUY MITEK, LLC

Arthroscopic irrigation/insufflation system
Primary Device ID10886705020591
NIH Device Record Key700c40e0-5c8e-4b27-a5a7-baf0a6c3552b
Commercial Distribution StatusIn Commercial Distribution
Brand NameFMS VUE
Version Model Number284002
Catalog Number284002
Company DUNS190572854
Company NameDEPUY MITEK, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Waste from Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Waste from Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Waste from Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Waste from Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Waste from Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Waste from Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Waste from Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Waste from Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Waste from Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Waste from Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Waste from Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Waste from Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Waste from Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Waste from Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Waste from Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Waste from Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Waste from Electrical and Electronic Equipment

Device Identifiers

Device Issuing AgencyDevice ID
GS110886705020591 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXARTHROSCOPE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-03-25
Device Publish Date2015-09-01

Devices Manufactured by DEPUY MITEK, LLC

20886705000903 - NA2025-09-29 SuperAnchor Threader Tab
10886705000951 - NA2025-09-29 SuperAnchor Threader Tab
10886705001088 - LUPINE ETHIBOND2025-09-29 LUPINE Loop PLUS Anchor w/ETHIBOND PLA Absorbable Anchor, size 2 (5 metric) green ETHIBOND braided polyester suture, 36 Inches (
10886705001958 - QUICKANCHOR PANACRYL2025-09-29 Rotator Cuff QUICKANCHOR Plus Size 2 (5 metric) PANACRYL braided absorbable suture 36 Inches (91cm), with CP-2 needles, with dis
10886705001989 - GII QUICKANCHOR PANACRYL2025-09-29 GII QUICKANCHOR Plus Size 2 (5 metric) PANACRYL braided absorbable suture 36 Inches (91cm), double armed with CP-2 needles, with
10886705001996 - QUICKANCHOR PANACRYL2025-09-29 Super QUICKANCHOR Plus Size 2 (5 metric) PANACRYL braided absorbable suture 36 Inches (91cm), double armed with CP-2 needles, wi
10886705002047 - ETHIBOND2025-09-29 Rotator Cuff EasyAnchor Size 2 (5 metric) green ETHIBOND braided polyester suture, 36 Inches (91cm), with disposable inserter
20886705002051 - ETHIBOND2025-09-29 Rotator Cuff EasyAnchor Size 2 (5 metric) green ETHIBOND braided polyester suture, 36 Inches (91cm), with disposable inserter

Trademark Results [FMS VUE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FMS VUE
FMS VUE
85340228 4576230 Live/Registered
FMS Future Medical System S.A.
2011-06-07

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