FDA.reportPublic FDA data

Fresenius Kabi Apheresis Needle with masterguard Anti-Stick Needle Protector

Primary DI
10842289102634
Brand
Fresenius Kabi Apheresis Needle with masterguard Anti-Stick Needle Protector
Company
NXSTAGE MEDICAL, INC.
Model
4R2441
Published
2020-06-09
Public version status
New
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
10842289102634PackageGS1250In Commercial Distribution
00842289102637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084228910263410842289102634
00842289102637008422891026378422891026370842289102637

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1.25Inch
Needle Gauge17Gauge

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
088013219
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
M535CAR170B0NXSTAGE CARTRIDGE EXPRESSCAR-170-B2015-09-01
M535CAR171B0NXSTAGE CARTRIDGE EXPRESSCAR-171-B2015-09-01
M535CAR171C0NXSTAGE CARTRIDGE EXPRESSCAR-171-C2015-09-01
M535CAR1720NXSTAGE CARTRIDGE EXPRESSCAR-1722015-09-01
M535NX1272NxStage Dosing CalculatorNX12722015-09-01
M535NX06420NXSTAGE LEAK DETECTION SENSOR AND TRAY ACCESSORY KITNX06422015-09-01
M535NX13480NXSTAGE LEAK DETECTION SENSOR AND TRAY ACCESSORY KITNX13482015-09-01
M535NX13730NXSTAGE LEAK DETECTION SENSOR AND TRAY ACCESSORY KITNX13732015-09-01
M535FW300WW0EXPRESS FLUID WARMERFW-300-WW2015-09-01
M535NX100010B0VersiHDNX1000-10-B2021-12-08
00842289103245NxStage PureFlow SolutionRFP-207-C2026-06-22
00842289103252NxStage PureFlow SolutionRFP-204-C2026-06-22
00842289103269NxStage PureFlow SolutionRFP-209-C2026-06-22
00842289103764EXPRESS FLUID WARMERFW-300-WW2026-04-29
00842289103689System One Cycler BaseNX06422026-04-22
00842289103696Extended Cycler Base and Filter HolderNX13482026-04-22
00842289103702Fluid Detection SystemNX13732026-04-22
00842289103719VersiHDNX1000-10-B2026-04-22
00842289103894VersiHD with GuideMe SoftwareNX1000-10-E2025-09-23
00842289104044VersiHD with GuideMe SoftwareNX1000-16-H2025-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04711552764857SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FIE2026-04-24
00842289102743masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102750masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102767masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102774masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102781masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102798masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102804masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102811masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102828masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102835masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102842masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102859masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102866masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102873masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102880masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102897masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102903masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102910masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102927masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102934masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102941masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102958masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102965masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102972masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102989masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102460ButtonHole SINGLE NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-06
00842289102590NxStage SINGLE NEEDLE FISTULA SETNXSTAGE MEDICAL, INC.FIE2020-07-06
00842289102644NxStage SINGLE NEEDLE FISTULA SETNXSTAGE MEDICAL, INC.FIE2020-07-06
00842289102668masterguard APHERESIS NEEDLENXSTAGE MEDICAL, INC.FIE2020-07-06