NoFact VIII

Basic Information

• Brand Name: NoFact VIII
• Primary DI: 10859394006153
• Version / Model: 68-201
• Catalog Number: 68-201
• 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: 39090041-f723-4e58-a3fe-7171eb0ca9df

Device Description

Factor VIII 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
56021	Coagulation factor VIII IVD, kit, clotting	A collection of reagents and other associated materials intended to be used for the quantitative measurement of coagulation factor VIII in a clinical specimen, using a clotting method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10859394006153	GS1
Unit of Use	00859394006156	GS1

Premarket Submissions

Submission Number	Supplement Number
K102851	000