TQE Plus Endotoxin 30" Filter Flat 222 Head

Basic Information

• Brand Name: TQE Plus Endotoxin 30" Filter Flat 222 Head
• Primary DI: 00868277000433
• Version / Model: TQE0.005-30P3E
• Company Name: NEPHROS, INC.
• Labeler DUNS: 120664557
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-21
• Public Version: 6
• Public Version Date: 2024-02-14
• Public Version Status: Update
• Public Device Record Key: 93b39d0f-a476-4c3a-8ed4-792be28be137
• Distribution End Date: 2024-02-13

Device Description

The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.

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: Yes
• Sterilization Methods: Liquid Chemical

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FIP	Subsystem, Water Purification	Gastroenterology, Urology	876.5665	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33627	Peritoneal dialysis system dialysate filter	A microporous device used to capture contamination particles of the dialysate before its instillation into the peritoneal cavity. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20868277000437	GS1	15 boxes per carton	15	Not in Commercial Distribution	2024-02-13
Package	10868277000430	GS1	1 part per box	1	Not in Commercial Distribution	2024-02-13
Primary	00868277000433	GS1

Premarket Submissions

Submission Number	Supplement Number
K161304	000