UltraCulture

Basic Information

• Brand Name: UltraCulture
• Primary DI: 00840075404231
• Version / Model: WVSP1104P200
• Catalog Number: WVSP1104P200
• Company Name: Lonza Walkersville, Inc.
• Labeler DUNS: 609095955
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-12
• Public Version: 1
• Public Version Date: 2024-03-20
• Public Version Status: New
• Public Device Record Key: 38883d91-58c7-4b7a-97dd-a7e85482d3b8

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Serial Number: No
• 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
KIT	Media And Components, Synthetic Cell And Tissue Culture	Hematology	864.2220	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58687	Enriched broth culture medium IVD	A broth culture medium supplemented with nutrient-rich substances (e.g., blood, serum) intended to enhance the growth and isolation of fastidious microorganisms, from a clinical specimen and/or culture isolate. It is typically used to cultivate microorganisms that would not otherwise grow in a general-purpose broth medium.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840075404231	GS1