UltraChek Reference Controls Normal

Basic Information

• Brand Name: UltraChek Reference Controls Normal
• Primary DI: 00831829000083
• Version / Model: 300-117
• Catalog Number: 300-117
• Company Name: SEPARATION TECHNOLOGY, INC.
• Labeler DUNS: 195501127
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 60
• Record Status: Published
• Publish Date: 2017-08-25
• Public Version: 3
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: d5400425-f1f6-44b6-86fe-edc4c5d37314

Device Description

For use only with the UltraCrit™ hematocrit measurement device and UltraCrit quality control (QC) cuvettes.

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: No
• 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
GKF	Instrument, Hematocrit, Automated	Hematology	864.5600	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56696	Haematocrit analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used to determine the red cell haematocrit or packed red cell volume of a whole blood specimen, using technology which may incorporate centrifugation, photometry or electrometry.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00831829000083	GS1
Unit of Use	00831829000090	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius