NoFact IX

Basic Information

• Brand Name: NoFact IX
• Primary DI: 10859394006160
• Version / Model: 69-201
• Catalog Number: 69-201
• Company Name: R 2 DIAGNOSTICS, INC.
• Labeler DUNS: 956610125
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-11-15
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 0eabeeb9-13a3-4bc6-bad5-e5a4461cc1ad

Device Description

Factor IX immunodepleted 10 x 1 ml

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GJT	Plasma, Coagulation Factor Deficient	Hematology	864.7290	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56031	Coagulation factor IX IVD, kit, clotting	A collection of reagents and other associated materials intended to be used for the quantitative detection of coagulation factor IX in a clinical specimen, using a clotting method. Factor IX deficiency may result in a hereditary bleeding disorder known as haemophilia B or Christmas disease.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10859394006160	GS1
Unit of Use	00859394006163	GS1

Premarket Submissions

Submission Number	Supplement Number
K102908	000