Starrsed Saline

Basic Information

• Brand Name: Starrsed Saline
• Primary DI: 08719189137200
• Version / Model: QRR010933
• Company Name: RR Mechatronics Manufacturing B.V.
• Labeler DUNS: 491828953
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-24
• Public Version: 1
• Public Version Date: 2023-08-01
• Public Version Status: New
• Public Device Record Key: d5c2c53d-5ca8-4831-a57a-02716dcc7880

Device Description

Product for automatic cleaning of Starrsed ESR analyzers

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
GKB	DEVICE, AUTOMATED SEDIMENTATION RATE	Hematology	864.5800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58236	Buffered wash solution IVD	A buffered wash solution intended to be used as a consumable reagent in combination with other IVDs during manual procedures or on-board an automated or semi-automated instrument for the processing, staining and/or testing of clinical laboratory specimens to neutralize/wash/rinse away excess reactants and/or to function as a wetting agent.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08719189137200	GS1

Customer Contacts

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