Medisystems Hemodialysis Fistula Needle Set with MasterGuard

GUDID 00842289100336

MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 16G X 1" LONG BEVEL WITH MASTERGUARD INCLUDED WITH TWINPACK D9-2006MGLB

MEDISYSTEMS CORPORATION

Haemodialysis needle
Primary Device ID00842289100336
NIH Device Record Keycb80c335-d4dd-4998-a770-e22903c5f415
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedisystems Hemodialysis Fistula Needle Set with MasterGuard
Version Model NumberD9-7006MGLB
Company DUNS061310132
Company NameMEDISYSTEMS CORPORATION
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com

Device Dimensions

Needle Gauge16 Gauge
Needle Gauge16 Gauge
Length1 Inch
Needle Gauge16 Gauge
Length1 Inch
Needle Gauge16 Gauge
Length1 Inch
Needle Gauge16 Gauge
Length1 Inch
Needle Gauge16 Gauge
Length1 Inch
Needle Gauge16 Gauge
Length1 Inch
Needle Gauge16 Gauge
Length1 Inch
Needle Gauge16 Gauge
Length1 Inch
Needle Gauge16 Gauge
Length1 Inch
Needle Gauge16 Gauge
Length1 Inch
Needle Gauge16 Gauge
Length1 Inch
Needle Gauge16 Gauge
Length1 Inch
Needle Gauge16 Gauge
Length1 Inch
Needle Gauge16 Gauge
Length1 Inch
Needle Gauge16 Gauge
Length1 Inch
Needle Gauge16 Gauge
Length1 Inch
Needle Gauge16 Gauge

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100842289100336 [Primary]

FDA Product Code

FIENeedle, Fistula

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-16

On-Brand Devices [Medisystems Hemodialysis Fistula Needle Set with MasterGuard]

00842289100480MEDISYSTEMS SINGLE PACK FISTULA NEEDLE SET 15G X 1" ROTATABLE HUB WITH MASTERGUARD INCLUDED WITH
00842289100459MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 16G X 1 1/4" WITH MASTERGUARD INCLUDED WITH TWINPACK D9-2
00842289100428MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 15G X 1 1/4" WITH MASTERGUARD INCLUDED WITH TWINPACK D9-2
00842289100398MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 17G X 1" LONG BEVEL WITH MASTERGUARD INCLUDED WITH TWINPA
00842289100367MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 17G X 1" WITH MASTERGUARD INCLUDED WITH TWINPACK D9-2007M
00842289100336MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 16G X 1" LONG BEVEL WITH MASTERGUARD INCLUDED WITH TWINPA
00842289100305MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 16G X 1" WITH MASTERGUARD INCLUDED WITH TWINPACK D9-2006M
00842289100275MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 15G X 1" LONG BEVEL WITH MASTERGUARD INCLUDED WITH TWINPA
00842289100244MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 15G X 1" WITH MASTERGUARD INCLUDED WITH TWINPACK D9-2005M
00842289100213MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 14G X 1" WITH MASTERGUARD INCLUDED WITH TWINPACK D9-2004M
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.