FDA.reportPublic FDA data

Fresenius Kabi Apheresis Needle with masterguard Anti-Stick Needle Protector

Primary DI
00842289102620
Brand
Fresenius Kabi Apheresis Needle with masterguard Anti-Stick Needle Protector
Company
NXSTAGE MEDICAL, INC.
Model
4R2440
Published
2020-06-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
10842289102627PackageGS1250In Commercial Distribution
00842289102620PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084228910262710842289102627
00842289102620008422891026208422891026200842289102620

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection needleA sterile, sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood collection set for drawing blood from a patient. It is intended to be connected to blood collection tubing and/or a blood collection Luer connector for transfer into a blood specimen receptacle. It may include a pre-attached blood collection tube spike however it does not include a blood collection tube holder. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1.25Inch
Needle Gauge16Gauge

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
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00842289104051VersiHD with GuideMe SoftwareNX1000-10-H2025-09-23
M535NX100010E0VersiHD with GuideMe softwareNX1000-10-E2023-08-21
M535RFP205WW0NxStage PureFlow SolutionRFP-205-WW2015-09-01
M535RFP205WW5NxStage PureFlow SolutionRFP-205-WW2015-09-01
M535NX100010G0VersiHD with GuideMe softwareNX1000-10-G2024-01-25
M535NX100010F0VersiHD with GuideMe softwareNX1000-10-F2023-08-21
M535NX100016F0VersiHD with GuideMe softwareNX1000-16-F2023-08-21
M535NX1272NxStage Dosing CalculatorNX12722015-09-01
00842289103870NXSTAGE CARTRIDGE EXPRESSCAR-170-E2024-07-24
00842289103887NXSTAGE CARTRIDGE EXPRESSCAR-172-E2024-07-24
M535NX01530NXSTAGE SYSTEM ONE - MOBILE STANDNX01532024-07-05
00842289103047NxStage PureFlow SolutionRFP-207-A2024-03-27
00842289103054NxStage PureFlow SolutionRFP-204-A2024-03-27

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