UF-CALIBRATOR

Basic Information

• Brand Name: UF-CALIBRATOR
• Primary DI: 04987562433698
• Version / Model: CN383000
• Company Name: SYSMEX CORPORATION
• Labeler DUNS: 690664461
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2018-05-31
• Public Version: 1
• Public Version Date: 2018-07-02
• Public Version Status: New
• Public Device Record Key: 3c199d54-e024-4983-95b2-f6362f55fe92

Device Description

UF-CALIBRATOR

Device Characteristics

• Single Use: No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JIW	Calibrator, surrogate	Clinical Chemistry	862.1150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42064	Urine sediment IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or semi-quantitative screening of urine sediment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04987562433698	GS1
Unit of Use	84987562433694	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	30	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius