masterguard plus HEMODIALYSIS FISTULA NEEDLE SET

GUDID 00842289102361

SINGLE PACK FISTULA NEEDLE 15G X 1" ROTATABLE HUB WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-6005MGP

NXSTAGE MEDICAL, INC.

Haemodialysis needle
Primary Device ID00842289102361
NIH Device Record Keyc6603ba4-a589-4ebc-8b64-d14b2686d48b
Commercial Distribution StatusIn Commercial Distribution
Brand Namemasterguard plus HEMODIALYSIS FISTULA NEEDLE SET
Version Model NumberD9-4005MGP
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

Device Dimensions

Needle Gauge15 Gauge
Length1 Inch
Needle Gauge15 Gauge
Length1 Inch
Needle Gauge15 Gauge
Length1 Inch
Needle Gauge15 Gauge
Length1 Inch
Needle Gauge15 Gauge
Length1 Inch
Needle Gauge15 Gauge
Length1 Inch
Needle Gauge15 Gauge
Length1 Inch
Needle Gauge15 Gauge
Length1 Inch
Needle Gauge15 Gauge
Length1 Inch
Needle Gauge15 Gauge
Length1 Inch
Needle Gauge15 Gauge
Length1 Inch
Needle Gauge15 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100842289102361 [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 Date2020-07-24
Device Publish Date2020-07-16

On-Brand Devices [masterguard plus HEMODIALYSIS FISTULA NEEDLE SET]

00842289102385SINGLE PACK FISTULA NEEDLE 15G X 1" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2005MGP
00842289102453SINGLE PACK FISTULA NEEDLE 16G X 1 1/4" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2016MGP
00842289102446SINGLE PACK FISTULA NEEDLE 15G X 1 1/4" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2015MGP
00842289102439SINGLE PACK FISTULA NEEDLE 17G X 1" LONG BEVEL WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2
00842289102422SINGLE PACK FISTULA NEEDLE 17G X 1" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2007MGP
00842289102415SINGLE PACK FISTULA NEEDLE 16G X 1" LONG BEVEL WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2
00842289102408SINGLE PACK FISTULA NEEDLE SET 16G X 1" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2006MGP
00842289102392SINGLE PACK FISTULA NEEDLE 15G X 1" LONG BEVEL WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2
00842289102378SINGLE PACK FISTULA NEEDLE 14G X 1" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2004MGP
10842289102863S9-7007MGPLB
10842289102856S9-7007MGP
00842289102361SINGLE PACK FISTULA NEEDLE 15G X 1" ROTATABLE HUB WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.