Medisystems Dialysis Priming Set

Basic Information

• Brand Name: Medisystems Dialysis Priming Set
• Primary DI: M535M494400
• Version / Model: M4-9440
• Company Name: NXSTAGE MEDICAL, INC.
• Labeler DUNS: 088013219
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-01
• Public Version: 4
• Public Version Date: 2020-10-20
• Public Version Status: Update
• Public Device Record Key: fb8c94d1-cb1a-4d1e-801d-1ad46d5d8dd0
• Distribution End Date: 2020-10-19

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: No
• 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
KOC	Accessories, Blood Circuit, Hemodialysis	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
Primary	M535M494400	HIBCC
Package	M535M494405	HIBCC		200	Not in Commercial Distribution	2020-10-19

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Protect from moisture, freezing and excessive heat