Streamline Airless System Set with Locksite Needleless Access Sites

Basic Information

• Brand Name: Streamline Airless System Set with Locksite Needleless Access Sites
• Primary DI: M535SL2000M2095W0
• Version / Model: SL-2000M2095W
• Company Name: NXSTAGE MEDICAL, INC.
• Labeler DUNS: 088013219
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 4
• Public Version Date: 2020-09-29
• Public Version Status: Update
• Public Device Record Key: 8e2b23dd-2605-424f-9d37-478a5a1f89e9
• Distribution End Date: 2020-09-28

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	876.5820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34999	Haemodialysis blood tubing set, single-use	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M535SL2000M2095W5	HIBCC		32	Not in Commercial Distribution	2020-09-28
Primary	M535SL2000M2095W0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]