ORTHO

Basic Information

• Brand Name: ORTHO
• Primary DI: 10758750005420
• Version / Model: 936380F
• Catalog Number: 936380F
• 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: 5
• Public Version Date: 2023-06-21
• Public Version Status: Update
• Public Device Record Key: 747787f4-efa9-4d3d-ac1a-4f16c172531d

Device Description

AutoWash 96, SLT/AutoWash 96, SLT, Refurbished

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MZA	TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN	Unknown		N

GMDN Terms

Code	Name	Definition	Implantable	Status
17489	Microplate washer IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for washing microplates containing multiple individual sample wells (i.e., the removal of biological specimen residue, stains, or impurities) by dispensing and aspirating measured volumes of washing solution as part of the processing required to perform an in vitro diagnostic assay.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10758750005420	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -15 – 45 Degrees Celsius