Starrsed Control

Basic Information

• Brand Name: Starrsed Control
• Primary DI: 08719189137118
• Version / Model: QRR049001
• 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: 2022-12-05
• Public Version: 1
• Public Version Date: 2022-12-13
• Public Version Status: New
• Public Device Record Key: 84b0a4b6-0959-40c0-a3a2-fb0dfff3a79e

Device Description

Control blood for Starrsed Instruments and procedures

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
55972	Erythrocyte sedimentation rate (ESR) IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative determination of erythrocyte sedimentation rate (ESR) of a whole blood clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	08719189137149	GS1	Blister Pack	6	In Commercial Distribution
Primary	08719189137118	GS1

Customer Contacts

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