FMS 284549

GUDID 20886705017451

FMS Fluid Management System Outflow Tubing with One-way valve (FMS DUO Plus)

DEPUY MITEK, LLC

Surgical irrigation tubing set, single-use
Primary Device ID20886705017451
NIH Device Record Key747ec361-79ed-4857-85a4-bbf030dc6a3e
Commercial Distribution StatusIn Commercial Distribution
Brand NameFMS
Version Model Number284549
Catalog Number284549
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Pallet 2 Stacked

Device Identifiers

Device Issuing AgencyDevice ID
GS110886705017454 [Primary]
GS120886705017451 [Package]
Contains: 30886705017458
Package: PACKAGE [24 Units]
In Commercial Distribution
GS130886705017458 [Package]
Contains: 10886705017454
Package: BOX [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXARTHROSCOPE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-04-23
Device Publish Date2017-03-17

On-Brand Devices [FMS]

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