FDA.reportPublic FDA data

Streamline Airless System Set with Locksite Needleless Access Sites and SecureCl

Primary DI
M535SL2000M2095L0
Brand
Streamline Airless System Set with Locksite Needleless Access Sites and SecureCl
Company
MEDISYSTEMS CORPORATION
Model
SL-2000M2095L
Published
2015-09-01
Public version status
Update
Distribution status
Not 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
FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FJKSet, Tubing, Blood, With And Without Anti-Regurgitation ValveGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M535SL2000M2095L5PackageHIBCC32Not in Commercial Distribution
M535SL2000M2095L0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis blood tubing set, single-useA collection of tubing segments and associated devices (e.g., connectors, clamps) intended to be used to transfer blood between a patient's vascular access device and a haemodialyser during haemodialysis; it is sometimes referred to as haemodialysis blood lines. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00Protect from moisture, freezing and excessive heat

Contacts#

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

Regulatory Flags#

DUNS number
061310132
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
M535M820062ViraGuard Viral Blocking Patient Transducer ProtectorM8-20062015-09-01
M535M89001E0Reverso Clamp Flow Reversing Interconnector for Hemodialysis Blood Tubing SetM8-9001E2015-09-01
M535SLE3000M30950Streamline Express Dialyzer with Pre-attached Tubing Set For Fresenius 2008 SeriSLE-3000M30952015-09-01
M535SLE3010M30960Streamline Express Dialyzer with Preattached Tubing Set For B.Braun Dialog SerieSLE-3010M30962015-09-01
M535SLE3011M30980Streamline Express Dialyzer with Preattached Tubing Set For B.Braun Dialog SerieSLE-3011M30982015-09-01
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
00842289100879Medisystems Hemodialysis Fistula Needle Set with MasterGuardS9-4005MG2016-09-16
00842289100886Medisystems Hemodialysis Fistula Needle Set with MasterGuardS9-4006MG2016-09-16
00842289100893Medisystems Hemodialysis Fistula Needle Set with MasterGuardS9-4007MG2016-09-16
00842289100909Medisystems Hemodialysis Fistula Needle Set with MasterGuardS9-4015MG2016-09-16
00842289100916Medisystems Hemodialysis Fistula Needle Set with MasterGuardS9-4016MG2016-09-16
00842289100923Medisystems Hemodialysis Fistula Needle Set with MasterGuardS9-4017MG2016-09-16
00842289100428Medisystems Hemodialysis Fistula Needle Set with MasterGuardD9-7015MG2016-09-16
00842289100435Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuardD9-2015MG2016-09-16
00842289100442Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuardD9-2015MG2016-09-16
00842289100459Medisystems Hemodialysis Fistula Needle Set with MasterGuardD9-7016MG2016-09-16
00842289100466Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuardD9-2016MG2016-09-16
00842289100473Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuardD9-2016MG2016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06948082774904NovaLineBain Medical Equipment (Guangzhou) Co., Ltd.FJK2026-06-04
06948082700729DORABain Medical Equipment (Guangzhou) Co., Ltd.FJK2026-05-13
04711552764666SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-24
04711552760026SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-23
04711552761498SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-23
04711552764048SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-23
04711552764086SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-23
04711552764758SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-23
08859915300017N/ATIANYI MEDICAL(THAILAND) LIMITEDFJK2026-01-01
008408611025185008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
008408611025255008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
008408611025325008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
008408611025565008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
008408611025635008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
008408611026005008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
008408611026245008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611025155008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611025225008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611025395008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611025535008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611025605008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611026075008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611026215008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
00860008016942Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16
00860008016973Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16
00860008016904Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16
00860008016911Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16
00860008016928Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16
00860008016959Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16
00860008016966Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16