masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS

GUDID 00842289102095

TWINPACK FISTULA NEEDLE SET 14G X 1" WITH MASTERGUARD PLUS Total Case Qty 250 (120 Twin pouches + 10 Single pouches)

NXSTAGE MEDICAL, INC.

Haemodialysis needle
Primary Device ID00842289102095
NIH Device Record Key82658248-fa08-4c1e-8f28-ed1d7c2afe87
Commercial Distribution StatusIn Commercial Distribution
Brand Namemasterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS
Version Model NumberD9-2004MGP
Company DUNS088013219
Company NameNXSTAGE MEDICAL, INC.
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

Device Dimensions

Needle Gauge14 Gauge
Length1 Inch
Needle Gauge14 Gauge
Length1 Inch
Needle Gauge14 Gauge
Length1 Inch
Needle Gauge14 Gauge
Length1 Inch
Needle Gauge14 Gauge
Length1 Inch
Needle Gauge14 Gauge
Length1 Inch
Needle Gauge14 Gauge
Length1 Inch
Needle Gauge14 Gauge
Length1 Inch
Needle Gauge14 Gauge
Length1 Inch
Needle Gauge14 Gauge
Length1 Inch
Needle Gauge14 Gauge
Length1 Inch
Needle Gauge14 Gauge
Length1 Inch
Needle Gauge14 Gauge
Length1 Inch

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100842289102095 [Primary]

FDA Product Code

FIENeedle, Fistula

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-16
Device Publish Date2020-07-08

On-Brand Devices [masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS]

00842289102125TWINPACK FISTULA NEEDLE SET 15G X 1" WITH MASTERGUARD PLUS Total Case Qty 250 (120 Twin pouches
00842289102118TWINPACK FISTULA NEEDLE SET 15G X 1" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2005MGP
00842289102286TWINPACK FISTULA NEEDLE SET 15G X 1" ROTATABLE HUB WITH MASTERGUARD PLUS Total Case Qty 250 (120
00842289102279TWINPACK FISTULA NEEDLE SET 15G X 1" ROTATABLE HUB WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK
00842289102262TWINPACK FISTULA NEEDLE SET 16G X 1 1/4" WITH MASTERGUARD PLUS Total Case Qty 250 (120 Twin pouc
00842289102255TWINPACK FISTULA NEEDLE SET 16G X 1 1/4" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2016MGP
00842289102248TWINPACK FISTULA NEEDLE SET 15G X 1 1/4" WITH MASTERGUARD PLUS Total Case Qty 250 (120 Twin pouc
00842289102231TWINPACK FISTULA NEEDLE SET 15G X 1 1/4" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2015MGP
00842289102224TWINPACK FISTULA NEEDLE SET 17G X 1" LONG BEVEL WITH MASTERGUARD PLUS Total Case Qty 250 (120 Tw
00842289102217TWINPACK FISTULA NEEDLE SET 17G X 1" LONG BEVEL WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-
00842289102200TWINPACK FISTULA NEEDLE SET 17G X 1" WITH MASTERGUARD PLUS Total Case Qty 250 (120 Twin pouches
00842289102194TWINPACK FISTULA NEEDLE SET 17G X 1" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2007MGP
00842289102187TWINPACK FISTULA NEEDLE SET 16G X 1" LONG BEVEL WITH MASTERGUARD PLUS Total Case Qty 250 (120 Tw
00842289102170TWINPACK FISTULA NEEDLE SET 16G X 1" LONG BEVEL WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-
00842289102163TWINPACK FISTULA NEEDLE SET 16G X 1" WITH MASTERGUARD PLUS Total Case Qty 250 (120 Twin pouches
00842289102156TWINPACK FISTULA NEEDLE SET 16G X 1" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2006MGP
00842289102149TWINPACK FISTULA NEEDLE SET 15G X 1" LONG BEVEL WITH MASTERGUARD PLUS Total Case Qty 250 (120 Tw
00842289102132TWINPACK FISTULA NEEDLE SET 15G X 1" LONG BEVEL WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-
00842289102101TWINPACK FISTULA NEEDLE SET 14G X 1" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2004MGP
00842289102095TWINPACK FISTULA NEEDLE SET 14G X 1" WITH MASTERGUARD PLUS Total Case Qty 250 (120 Twin pouches
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