Cultura™

Basic Information

• Brand Name: Cultura™
• Primary DI: 10884450520120
• Version / Model: 10884450520120
• Catalog Number: C100F/G
• Company Name: Merit Medical Systems, Inc.
• Labeler DUNS: 184763290
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 250
• Record Status: Published
• Publish Date: 2022-10-05
• Public Version: 1
• Public Version Date: 2022-10-13
• Public Version Status: New
• Public Device Record Key: 0738cffb-8592-439d-b42c-cc3518f8efd3

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KXG	Applicator, absorbent tipped, sterile	General Hospital	880.6025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57940	Oral/upper respiratory tract specimen collection swab	A piece of absorbent or non-absorbent material, with no additives, detached or on a stick, and intended to be used by a healthcare professional for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for culture, analysis, and/or other investigation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884450520127	GS1		4	In Commercial Distribution
Primary	10884450520120	GS1
Unit of Use	00884450520123	GS1