HemataSTAT II Centrifuge (Refurbished)

Basic Information

• Brand Name: HemataSTAT II Centrifuge (Refurbished)
• Primary DI: 00831829000397
• Version / Model: R100-100
• Catalog Number: R100-100
• Company Name: SEPARATION TECHNOLOGY, INC.
• Labeler DUNS: 195501127
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-17
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 207b6e93-63fe-495d-a04c-d11e76e753d0

Device Description

HemataStat II Microhematocrit System is a small, lightweight centrifuge which provides a rapid and accurate mircohematocrit determination using capillary or venous blood samples.

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: Yes
• 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
GKG	Centrifuge, Hematocrit	Hematology	864.6400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32429	Microhaematocrit centrifuge IVD	An electrically-powered device intended to be used for the processing of whole blood specimens using centrifugal force to determine the haematocrit, i.e., the ratio of red blood cell volume to whole blood volume expressed as a decimal, fraction, or percentage. The device typically requires a smaller sample volume than conventional centrifuges (macrohaematocrit method). The haematocrit is typically used to diagnose blood loss and erythrocyte count above or below normal.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00831829000397	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 60 Degrees Celsius