FDA.reportPublic FDA data

Dialysate Sack (SAK) with Concentrate

Primary DI
M535SAK407A0
Brand
Dialysate Sack (SAK) with Concentrate
Company
NXSTAGE MEDICAL, INC.
Model
SAK-407-A
Published
2015-10-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FKRSubsystem, Proportioning

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FKRSubsystem, ProportioningGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M535SAK407A5PackageHIBCC2In Commercial Distribution
M535SAK407A0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis concentrateA product intended to be mixed with water to prepare a solution with an electrolyte composition similar to that of blood (i.e., a dialysate) for the exchange of solutes with blood through a semi-permeable membrane in the dialyser of a haemodialysis system. It is intended to remove metabolic waste from the blood to help maintain physiological blood electrolyte and pH levels. The product typically includes glucose and salts of the following constituents: sodium, potassium, magnesium, calcium, chloride, and anions of weak acids [e.g., bicarbonate (HCO3), acetate, citrate]. It is supplied as a solution or a dry powder. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

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

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
M535NX200011D0PUREFLOW SLNXSTAGE MEDICAL, INC.FKR2023-12-04
M535NX200010D0PUREFLOW SLNXSTAGE MEDICAL, INC.FKR2023-12-04
M535NX200011A0PUREFLOW SLNXSTAGE MEDICAL, INC.FKR2023-06-21
M535NX20002A0PUREFLOW SLNXSTAGE MEDICAL, INC.FKR2016-11-17
M535NX20001CAN0PUREFLOW SL - CONTROL UNITNXSTAGE MEDICAL, INC.FKR2016-07-21
M535NX20002CAN0PUREFLOW SL - CHASSISNXSTAGE MEDICAL, INC.FKR2016-07-21
M535SAK301A0Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-10-30
M535SAK302A0Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-10-30
M535SAK303A0Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-10-30
M535SAK304A0Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-10-30
M535SAK305A0Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-10-30
M535SAK306A0Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-10-30
M535SAK307A0Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-10-30
M535SAK401A0Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-10-30
M535SAK402A0Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-10-30
M535SAK403A0Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-10-30
M535SAK404A0Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-10-30
M535SAK405A0Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-10-30
M535SAK406A0Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-10-30
M535NX2000100PUREFLOW SLNXSTAGE MEDICAL, INC.FKR2015-09-02
M535SAK4020Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-09-02
M535SAK4030Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-09-02
M535SAK4070Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-09-02
M535NX200010PUREFLOW SLNXSTAGE MEDICAL, INC.FKR2015-09-01
M535NX2000110PUREFLOW SL KITNXSTAGE MEDICAL, INC.FKR2015-09-01
M535NX200011EU0PUREFLOW SLNXSTAGE MEDICAL, INC.FKR2015-09-01
M535NX20001A0PUREFLOW SLNXSTAGE MEDICAL, INC.FKR2015-09-01
M535NX200020PUREFLOW SLNXSTAGE MEDICAL, INC.FKR2015-09-01
M535NX20002EU0PUREFLOW SLNXSTAGE MEDICAL, INC.FKR2015-09-01
M535NX200040PUREFLOW SLNXSTAGE MEDICAL, INC.FKR2015-09-01