masterguard APHERESIS NEEDLE

GUDID 10842289102726

NXSTAGE MEDICAL, INC.

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Primary Device ID10842289102726
NIH Device Record Key6a4ba614-ae7c-4350-bb85-af19a1de6531
Commercial Distribution StatusIn Commercial Distribution
Brand Namemasterguard APHERESIS NEEDLE
Version Model NumberP9-7117MG
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
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com

Device Dimensions

Needle Gauge17 Gauge
Length1.25 Inch
Needle Gauge17 Gauge
Length1.25 Inch
Needle Gauge17 Gauge
Length1.25 Inch
Needle Gauge17 Gauge
Length1.25 Inch
Needle Gauge17 Gauge
Length1.25 Inch
Needle Gauge17 Gauge
Length1.25 Inch
Needle Gauge17 Gauge
Length1.25 Inch
Needle Gauge17 Gauge
Length1.25 Inch
Needle Gauge17 Gauge
Length1.25 Inch
Needle Gauge17 Gauge
Length1.25 Inch
Needle Gauge17 Gauge
Length1.25 Inch
Needle Gauge17 Gauge
Length1.25 Inch
Needle Gauge17 Gauge
Length1.25 Inch
Needle Gauge17 Gauge
Length1.25 Inch
Needle Gauge17 Gauge
Length1.25 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
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
GS100842289102729 [Primary]
GS100842289102729 [Primary]
GS100842289102729 [Primary]
GS100842289102729 [Primary]
GS100842289102729 [Primary]
GS100842289102729 [Primary]
GS100842289102729 [Primary]
GS100842289102729 [Primary]
GS100842289102729 [Primary]
GS100842289102729 [Primary]
GS100842289102729 [Primary]
GS100842289102729 [Primary]
GS100842289102729 [Primary]
GS100842289102729 [Primary]
GS100842289102729 [Primary]
GS110842289102726 [Package]
Contains: 00842289102729
Package: Shipping Box [250 Units]
In Commercial Distribution
GS110842289102726 [Package]
Contains: 00842289102729
Package: Shipping Box [250 Units]
In Commercial Distribution
GS110842289102726 [Package]
Contains: 00842289102729
Package: Shipping Box [250 Units]
In Commercial Distribution
GS110842289102726 [Package]
Contains: 00842289102729
Package: Shipping Box [250 Units]
In Commercial Distribution
GS110842289102726 [Package]
Contains: 00842289102729
Package: Shipping Box [250 Units]
In Commercial Distribution
GS110842289102726 [Package]
Contains: 00842289102729
Package: Shipping Box [250 Units]
In Commercial Distribution
GS110842289102726 [Package]
Contains: 00842289102729
Package: Shipping Box [250 Units]
In Commercial Distribution
GS110842289102726 [Package]
Contains: 00842289102729
Package: Shipping Box [250 Units]
In Commercial Distribution
GS110842289102726 [Package]
Contains: 00842289102729
Package: Shipping Box [250 Units]
In Commercial Distribution
GS110842289102726 [Package]
Contains: 00842289102729
Package: Shipping Box [250 Units]
In Commercial Distribution
GS110842289102726 [Package]
Contains: 00842289102729
Package: Shipping Box [250 Units]
In Commercial Distribution
GS110842289102726 [Package]
Contains: 00842289102729
Package: Shipping Box [250 Units]
In Commercial Distribution
GS110842289102726 [Package]
Contains: 00842289102729
Package: Shipping Box [250 Units]
In Commercial Distribution
GS110842289102726 [Package]
Contains: 00842289102729
Package: Shipping Box [250 Units]
In Commercial Distribution
GS110842289102726 [Package]
Contains: 00842289102729
Package: Shipping Box [250 Units]
In Commercial Distribution

FDA Product Code

FIENeedle, Fistula
FIENeedle, Fistula
FIENeedle, Fistula
FIENeedle, Fistula
FIENeedle, Fistula
FIENeedle, Fistula
FIENeedle, Fistula
FIENeedle, Fistula
FIENeedle, Fistula
FIENeedle, Fistula
FIENeedle, Fistula
FIENeedle, Fistula
FIENeedle, Fistula
FIENeedle, Fistula
FIENeedle, Fistula

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-17
Device Publish Date2020-06-09

Devices Manufactured by NXSTAGE MEDICAL, INC.

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00842289102125 - masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS2020-06-17 TWINPACK FISTULA NEEDLE SET 15G X 1" WITH MASTERGUARD PLUS Total Case Qty 250 (120 Twin pouches + 10 Single pouches)
00842289102385 - masterguard plus HEMODIALYSIS FISTULA NEEDLE SET2020-06-17 SINGLE PACK FISTULA NEEDLE 15G X 1" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2005MGP
00842289102620 - Fresenius Kabi Apheresis Needle with masterguard Anti-Stick Needle Protector2020-06-17
10842289102634 - Fresenius Kabi Apheresis Needle with masterguard Anti-Stick Needle Protector2020-06-17
10842289102726 - masterguard APHERESIS NEEDLE2020-06-17
10842289102726 - masterguard APHERESIS NEEDLE2020-06-17
M535NX3302A0 - NXView Touch Monitor2020-03-19
M535CAR124C5 - NXSTAGE CARTRIDGE2019-06-07

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