FDA.reportPublic FDA data

Streamline Airless System Set with Locksite Needleless Access Sites

Primary DI
M535SL2000M2095D0
Brand
Streamline Airless System Set with Locksite Needleless Access Sites
Company
MEDISYSTEMS CORPORATION
Model
SL-2000M2095D
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
M535SL2000M2095D5PackageHIBCC36Not in Commercial Distribution
M535SL2000M2095D0PrimaryHIBCC0

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
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
00383790011877SLIMLINE™ BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETNIPRO MEDICAL CORPORATIONFJK2025-06-01