RPI-Check

Basic Information

• Brand Name: RPI-Check
• Primary DI: 08719189137477
• Version / Model: A0016912
• Company Name: Mechatronics USA LLC
• Labeler DUNS: 137005943
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-05
• Public Version: 1
• Public Version Date: 2022-12-13
• Public Version Status: New
• Public Device Record Key: 5eae7830-ff11-44a2-8d8e-8936a3da1ea2

Device Description

Reagent for instrument

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: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Liquid Chemical

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JCE	SOLUTION, ISOTONIC	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43674	Isotonic saline reagent IVD	An unbuffered isotonic saline solution intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	08719189137538	GS1	Box	12	In Commercial Distribution
Primary	08719189137477	GS1

Customer Contacts

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