Medisystems TwinPack Hemodialysis Fistula Needle Set with Masterguard Plus

GUDID 00842289101357

MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 16G X 1" LONG BEVEL WITH MASTERGUARD PLUS Total Case Qty 250 (120 Twin pouches + 10 Single pouches)

MEDISYSTEMS CORPORATION

Haemodialysis needle
Primary Device ID00842289101357
NIH Device Record Key1e6e1859-e0f6-4e68-9b30-925ba811c1c8
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedisystems TwinPack Hemodialysis Fistula Needle Set with Masterguard Plus
Version Model NumberD9-2006MGPLB
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

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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100842289101357 [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 Date2017-10-24

On-Brand Devices [Medisystems TwinPack Hemodialysis Fistula Needle Set with Masterguard Plus]

00842289101814MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 16G X 1" WITH MASTERGUARD PLUS Total Case Qty 250 (120 T
00842289101791MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 16G X 1" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9
00842289101784MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 15G X 1" WITH MASTERGUARD PLUS Total Case Qty 250 (120 T
00842289101760MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 15G X 1" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9
00842289101500MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 15G X 1" ROTATABLE HUB WITH MASTERGUARD PLUS Total Case
00842289101487MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 15G X 1" ROTATABLE HUB WITH MASTERGUARD PLUS INCLUDED WI
00842289101470MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 16G X 1 1/4" WITH MASTERGUARD PLUS Total Case Qty 250 (1
00842289101463MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 16G X 1 1/4" WITH MASTERGUARD PLUS INCLUDED WITH TWINPAC
00842289101449MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 15G X 1 1/4" WITH MASTERGUARD PLUS Total Case Qty 250 (1
00842289101432MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 15G X 1 1/4" WITH MASTERGUARD PLUS INCLUDED WITH TWINPAC
00842289101418MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 17G X 1" LONG BEVEL WITH MASTERGUARD PLUS Total Case Qty
00842289101395MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 17G X 1" LONG BEVEL WITH MASTERGUARD PLUS INCLUDED WITH
00842289101388MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 17G X 1" WITH MASTERGUARD PLUS Total Case Qty 250 (120 T
00842289101364MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 17G X 1" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9
00842289101357MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 16G X 1" LONG BEVEL WITH MASTERGUARD PLUS Total Case Qty
00842289101333MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 16G X 1" LONG BEVEL WITH MASTERGUARD PLUS INCLUDED WITH
00842289101326MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 15G X 1" LONG BEVEL WITH MASTERGUARD PLUS Total Case Qty
00842289101302MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 15G X 1" LONG BEVEL WITH MASTERGUARD PLUS INCLUDED WITH
00842289101296MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 14G X 1" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9
00842289101289MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 14G X 1" WITH MASTERGUARD PLUS Total Case Qty 250 (120 T
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.