ESR-10 Manual Rack

Basic Information

• Brand Name: ESR-10 Manual Rack
• Primary DI: 00844509002123
• Version / Model: 240321
• Catalog Number: 240321
• Company Name: STRECK, INC.
• Labeler DUNS: 072915986
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 8875c98a-9037-489d-b3d2-91b2a08459ac

Device Description

A 10-position manual Modified Westergren system used for determining the erythrocyte sedimentation rate (ESR) of whole blood in 30 minutes using 1.2ml Streck ESR-Vacuum Tubes.

Device Characteristics

• Single Use: No
• 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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
GKB	Device, Automated Sedimentation Rate	Hematology	864.5800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58170	Erythrocyte sedimentation rate (ESR) rack IVD, scaled measure	A dedicated, non-sterile, rack with a build-in graduated scale ruler, with or without a programmable timer or stop-clock, intended to be used to hold erythrocyte sedimentation rate (ESR) tubes containing unmarked columns of blood in an upright and secured position, as required when performing a manual estimation of the ESR of a whole blood clinical specimen. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00844509002123	GS1

Customer Contacts

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