Medisystems Hemodialysis Blood Tubing Sets

Basic Information

• Brand Name: Medisystems Hemodialysis Blood Tubing Sets
• Primary DI: M535B33632M37050
• Version / Model: B3-3632M3705
• Company Name: MEDISYSTEMS CORPORATION
• Labeler DUNS: 061310132
• 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: 2020-09-29
• Public Version Status: Update
• Public Device Record Key: 46d3ac5c-5eb3-45c1-95ed-646cf5221e84
• 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	M535B33632M37055	HIBCC		12	Not in Commercial Distribution	2020-09-28
Primary	M535B33632M37050	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Protect from moisture, freezing and excessive heat
• Type: Storage Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius