FMS 284504

GUDID 20886705017390

FMS Fluid Management System Inflow Tubing (FMS DUO Plus or FMS Solo)

DEPUY MITEK, LLC

Arthroscopic shaver system blade, single-use

Primary Device ID	20886705017390
NIH Device Record Key	4cd18f67-30a1-4725-b4f8-9d354e833143
Commercial Distribution Status	In Commercial Distribution
Brand Name	FMS
Version Model Number	284504
Catalog Number	284504
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	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
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
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx

Operating and Storage Conditions

Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Pallet 2 Stacked
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Pallet 2 Stacked
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Pallet 2 Stacked
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Pallet 2 Stacked
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Pallet 2 Stacked
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Pallet 2 Stacked
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Pallet 2 Stacked
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Pallet 2 Stacked
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Pallet 2 Stacked
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Pallet 2 Stacked
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Pallet 2 Stacked
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Pallet 2 Stacked
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Pallet 2 Stacked
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Pallet 2 Stacked
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Pallet 2 Stacked
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Pallet 2 Stacked
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Pallet 2 Stacked
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Pallet 2 Stacked
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Pallet 2 Stacked
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Pallet 2 Stacked
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Pallet 2 Stacked
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Pallet 2 Stacked
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Pallet 2 Stacked
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Temperature	Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705017393 [Primary]
GS1	20886705017390 [Package] Contains: 10886705017393 Package: PACKAGE [24 Units] In Commercial Distribution
GS1	30886705017397 [Package] Contains: 10886705017393 Package: BOX [12 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K951843

FDA Product Code

HRX	ARTHROSCOPE

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2022-07-04
Device Publish Date	2015-09-01

On-Brand Devices [FMS]

20886705016065	FMS Waste Collection Bag
20886705023230	FMS Fluid Management System Outflow Tubing with One-Way valve (FMS VUE or FMS DUO Plus)
30886705023220	FMS Fluid Management System Outflow Tubing without One-Way valve (FMS VUE or FMS DUO Plus)
30886705023060	FMS Fluid Management System Inflow Tubing (FMS VUE)
20886705017451	FMS Fluid Management System Outflow Tubing with One-way valve (FMS DUO Plus)
20886705017437	FMS Patient Set Without One-Way Valve Arthroscopy Tubing
10886705016358	FMS Obturator for Cannulas 281580
20886705015907	FMS Fluid Management System Intermediary Tubing with One-way valve
20886705015853	FMS Gravity Tubing
20886705015761	FMS Fluid Management System Intermediary Tubing Without One-Way valve
10886705016327	fms Obturator for Cannulas 281572
10886705023769	FMS INFLOW/OUTFLOW SHEATH KIT Inflow/Outflow-Linvatec
10886705023752	FMS INFLOW/OUTFLOW SHEATH KIT Inflow/Outflow Sheath-Wolf
10886705023745	FMS INFLOW/OUTFLOW SHEATH KIT Inflow/Outflow Sheath-Stryker
10886705023738	FMS INFLOW/OUTFLOW SHEATH KIT Inflow/Outflow Sheath-Storz
10886705023721	FMS INFLOW/OUTFLOW SHEATH KIT Inflow/Outflow Sheath-Smith & Nephew
10886705023714	FMS INFLOW/OUTFLOW SHEATH KIT Inflow/Outflow Sheath-Olympus
10886705023660	FMS INFLOW/OUTFLOW SHEATH Obturator Inflow/Outflow-Wolf
10886705023653	FMS INFLOW/OUTFLOW SHEATH Obturator Inflow/Outflow-Stryker
10886705023646	FMS INFLOW/OUTFLOW SHEATH Obturator Inflow/Outflow-Storz
10886705023639	FMS INFLOW/OUTFLOW SHEATH Obturator Inflow/Outflow-Smith & Nephew
10886705023622	FMS INFLOW/OUTFLOW SHEATH Obturator Inflow/Outflow-Olympus
10886705023615	FMS INFLOW/OUTFLOW SHEATH Obturator Inflow/Outflow-Linvatec
10886705018369	FMS Remote Control For FMS SOLO
10886705017256	FMS 4 Way Foot Pedal For FMS DUO Plus
10886705017249	FMS 2 Way Foot Pedal for FMS DUO PLUS
10886705017232	FMS 1 Way Foot Pedal for FMS SOLO
10886705016341	fms Trocar for Cannulas 281580
10886705016440	FMS Hand Control Interface To Arthrex Adapteur Power System II
20886705016331	FMS Fluid Management System 4.5mm FMS Outflow Cannula
20886705016317	FMS Fluid Management System 2.5mm FMS Outflow Cannula
10886705020478	FMS Fluid Management System FMS CONNECT Interface Cable - DUO PLUS/SOLO
20886705025494	FMS Round Tornado Burr Plus 5.0mm
20886705025449	FMS Round Burr Plus 5.0mm
20886705025432	FMS Round Tornado Burr Plus 4.0mm
20886705025425	FMS Round Burr Plus 4.0mm
20886705025111	FMS XL ROUND TORNADO BURR PLUS 5.0mm
20886705025104	FMS XL ROUND BURR PLUS 5.0mm
20886705025098	FMS XL ROUND TORNADO BURR PLUS 4.0mm
20886705025081	FMS XL ROUND BURR PLUS 4.0mm
20886705025067	FMS XL ULTRA-AGGRESSIVE RADIUS BLADE PLUS 4.2mm
20886705025050	FMS XL AGGRESSIVE BLADE PLUS 4.2mm
20886705025043	FMS XL FULL RADIUS BLADE PLUS 4.2mm
20886705025036	FMS XL MULTI BLADE PLUS 4.2mm
20886705023094	FMS BARREL BURR PLUS 5.0mm FOR USE with FMS DUO+ System
20886705023087	FMS BARREL BURR PLUS 5.0mm
20886705022226	FMS ULTRA-AGGRESSIVE BLADE PLUS 4.0mm
20886705022103	FMS BARREL TORNADO BURR PLUS 5.0mm
20886705022097	FMS MULTI BLADE PLUS 5.0mm
20886705022080	FMS ULTRA-AGGRESSIVE BLADE PLUS 5.0mm