VisuCon-F Frozen Normal Control Plasma

Basic Information

• Brand Name: VisuCon-F Frozen Normal Control Plasma
• Primary DI: 10629009051256
• Version / Model: FRNCP0125
• Company Name: Affinity Biologicals Inc
• Labeler DUNS: 249373515
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2017-04-28
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 32782de4-e80c-4600-a337-a06d7a76945b

Device Description

Intended for use in the quality control of coagulation assays in the normal range.

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
GGN	Plasma, Coagulation Control	Hematology	864.5425	2

GMDN Terms

Code	Name	Definition	Implantable	Status
30590	Multiple coagulation factor IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10629009051256	GS1
Unit of Use	10629009050013	GS1
Previous	16290090051254	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K091284	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at or below -60°C.