Globe Scientific

Basic Information

• Brand Name: Globe Scientific
• Primary DI: 00840095605960
• Version / Model: 3469R
• Company Name: GLOBE SCIENTIFIC INC.
• Labeler DUNS: 106793995
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2019-11-26
• Public Version: 1
• Public Version Date: 2019-12-04
• Public Version Status: New
• Public Device Record Key: f0852ab9-dbee-43bf-8dcd-9fd1d2224c9a

Device Description

ESR: Sedi-Rate Westergren System with 10-Place PS Rack, Pipettes and Citrate Vials, 100 Tests/Box

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: Labeling does not contain MRI Safety Information
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GHC	Tube, Sedimentation Rate	Hematology	864.6700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
55974	Non-evacuated erythrocyte sedimentation rate (ESR) tube IVD	An open-ended glass or plastic tube, or other dedicated vessel, intended to be used alone or in combination with other IVDs (e.g., ESR analyser, scaled ruler) for the quantitative determination of the erythrocyte sedimentation rate (ESR) of a whole blood clinical specimen. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840095605960	GS1
Unit of Use	00840095611008	GS1