FDA.reportPublic FDA data

Medisystems Hemodialysis Fistula Needle Set with Masterguard Plus

Primary DI
00842289101746
Brand
Medisystems Hemodialysis Fistula Needle Set with Masterguard Plus
Company
MEDISYSTEMS CORPORATION
Model
S9-7615MGP
Published
2017-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FIENeedle, Fistula

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FIENeedle, FistulaGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10842289101743PackageGS1200In Commercial Distribution
00842289101746PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084228910174310842289101743
00842289101746008422891017468422891017460842289101746

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis needleA sterile, sharp bevel-edged, hollow tubular metal instrument used to remove and return a patient's blood during a haemodialysis procedure. Commonly known as a dialysis needle. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1.25Inch
Needle Gauge15Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-866-697-8243info@nxstage.com

Regulatory Flags#

DUNS number
061310132
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M535M820062ViraGuard Viral Blocking Patient Transducer ProtectorM8-20062015-09-01
M535SLE3000M30955Streamline Express Dialyzer with Pre-attached Tubing Set For Fresenius 2008 SeriSLE-3000M30952015-09-01
M535SLE3010M30965Streamline Express Dialyzer with Preattached Tubing Set For B.Braun Dialog SerieSLE-3010M30962015-09-01
M535SLE3011M30985Streamline Express Dialyzer with Preattached Tubing Set For B.Braun Dialog SerieSLE-3011M30982015-09-01
M535M850075Medisystems Medic Anti-stick Needle/ConnectorM8-50072016-09-16
10842289100517Medisystems Button Hole Needle Set with SteriPickBH-4005PE2016-09-16
10842289100524Medisystems Button Hole Needle Set with SteriPickBH-7005PE2016-09-16
10842289100531Medisystems Button Hole Needle Set with SteriPickBH-4006PE2016-09-16
10842289100562Medisystems Button Hole Needle Set with SteriPickBH-7006PE2016-09-16
10842289100579Medisystems Button Hole Needle Set with SteriPickBH-7004PE2016-09-16
10842289100609Medisystems Button Hole Needle SetBH-70142016-09-16
10842289100616Medisystems Button Hole Needle SetBH-70152016-09-16
10842289100623Medisystems Button Hole Needle SetBH-70162016-09-16
10842289100678Medisystems Button Hole Needle Set with SteriPickBH-7605PE2016-09-16
10842289100692Medisystems Button Hole Needle Set with SteriPickBH-7606PE2016-09-16
10842289100708Medisystems Button Hole Needle SetBH-76152016-09-16
10842289100715Medisystems Button Hole Needle SetBH-76162016-09-16
M535B33632M37055Medisystems Hemodialysis Blood Tubing SetsB3-3632M37052015-09-01
M535B34630M47055Medisystems Hemodialysis Blood Tubing SetsB3-4630M47052015-09-01
M535B36604M67925Medisystems Hemodialysis Blood Tubing SetsB3-6604M67922015-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08888483007967JMS CAVEO A.V. Fistula Needle SetJMS SINGAPORE PTE LTDFIE2025-08-26
16948082746083DORABain Medical Equipment (Guangzhou) Co., Ltd.FIE2023-04-11
16948082746090DORABain Medical Equipment (Guangzhou) Co., Ltd.FIE2023-04-11
06948082746109DORABain Medical Equipment (Guangzhou) Co., Ltd.FIE2023-04-11
16948082746113DORABain Medical Equipment (Guangzhou) Co., Ltd.FIE2023-04-11
16948082749688DORABain Medical Equipment (Guangzhou) Co., Ltd.FIE2023-04-11
16948082749695DORABain Medical Equipment (Guangzhou) Co., Ltd.FIE2023-04-11
16948082749701DORABain Medical Equipment (Guangzhou) Co., Ltd.FIE2023-04-11
00842289102361masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-16
10842289102856masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
10842289102863masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102095masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETSNXSTAGE MEDICAL, INC.FIE2020-07-08
00842289102101masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETSNXSTAGE MEDICAL, INC.FIE2020-07-08
00842289102132masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETSNXSTAGE MEDICAL, INC.FIE2020-07-08
00842289102149masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETSNXSTAGE MEDICAL, INC.FIE2020-07-08
00842289102156masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETSNXSTAGE MEDICAL, INC.FIE2020-07-08
00842289102163masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETSNXSTAGE MEDICAL, INC.FIE2020-07-08
00842289102170masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETSNXSTAGE MEDICAL, INC.FIE2020-07-08
00842289102187masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETSNXSTAGE MEDICAL, INC.FIE2020-07-08
00842289102194masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETSNXSTAGE MEDICAL, INC.FIE2020-07-08
00842289102200masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETSNXSTAGE MEDICAL, INC.FIE2020-07-08
00842289102217masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETSNXSTAGE MEDICAL, INC.FIE2020-07-08
00842289102224masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETSNXSTAGE MEDICAL, INC.FIE2020-07-08
00842289102231masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETSNXSTAGE MEDICAL, INC.FIE2020-07-08
00842289102248masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETSNXSTAGE MEDICAL, INC.FIE2020-07-08
00842289102255masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETSNXSTAGE MEDICAL, INC.FIE2020-07-08
00842289102262masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETSNXSTAGE MEDICAL, INC.FIE2020-07-08
00842289102279masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETSNXSTAGE MEDICAL, INC.FIE2020-07-08
00842289102286masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETSNXSTAGE MEDICAL, INC.FIE2020-07-08
00842289102378masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-08