Vacuette

Basic Information

• Brand Name: Vacuette
• Primary DI: 29120017578189
• Version / Model: 836077
• Catalog Number: 836077
• Company Name: Greiner Bio-One GmbH
• Labeler DUNS: 303639066
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-30
• Public Version: 1
• Public Version Date: 2020-10-08
• Public Version Status: New
• Public Device Record Key: 9ec5dfcb-1bed-4ea5-996c-927e08634812

Device Description

ESR Rack with graduation for 729073 / 729093

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JPH	TEST, ERYTHROCYTE SEDIMENTATION RATE	Hematology	864.6700	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
Package	39120017578186	GS1		8	In Commercial Distribution
Primary	29120017578189	GS1