Uricult® CLED/MacConkey

Basic Information

• Brand Name: Uricult® CLED/MacConkey
• Primary DI: 06438115000020
• Version / Model: 68019
• Catalog Number: 1001
• Company Name: Aidian Oy
• Labeler DUNS: 401656868
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-05-13
• Public Version: 5
• Public Version Date: 2020-03-02
• Public Version Status: Update
• Public Device Record Key: f089692e-2ba5-48e5-8933-8aa045d9a9fe

Device Description

A dip slide culture method for the detection of bacteriuria and the presumptive identification of uropathogens.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
JSH	Culture Media, Non-Selective And Differential	Microbiology	866.2320	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62106	Multiple formulation agar culture medium IVD	A combination of two or more selective, differential and/or enriched agar culture media formulations separately contained within a single petri dish (commonly referred to as a split plate) or dip slide and intended to be used for the simultaneous growth, selective isolation and/or differentiation of microorganisms from a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06438115000020	GS1
Unit of Use	06438115001072	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 45 – 77 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 7 – 25 Degrees Celsius