ORTHO

Basic Information

• Brand Name: ORTHO
• Primary DI: 10758750007554
• Version / Model: 6902096
• Catalog Number: 6902096
• Company Name: ORTHO-CLINICAL DIAGNOSTICS, INC.
• Labeler DUNS: 068715424
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-24
• Public Version: 4
• Public Version Date: 2023-06-21
• Public Version Status: Update
• Public Device Record Key: 0f45829c-3251-453e-959a-ff381d112655

Device Description

ORTHO® Confidence System

Device Characteristics

• Single Use: No
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KSF	KIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS	Hematology	864.9650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45310	Multiple immunohaematology test IVD, control	A collection of reagent red blood cells and/or immunoglobulins directed at red blood cell antigens that are supplied together and intended to be used when testing a clinical specimen to verify the performance of multiple immunohaematological tests.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10758750007554	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius