AVANOS

Basic Information

• Brand Name: AVANOS
• Primary DI: 00350770927459
• Version / Model: 92745
• Catalog Number: 60480
• Company Name: Avanos Medical, Inc.
• Labeler DUNS: 079375431
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2019-07-24
• Public Version: 1
• Public Version Date: 2019-08-01
• Public Version Status: New
• Public Device Record Key: 391d058d-9e1c-4758-aca6-a2bba39aefdc

Device Description

AVANOS* CLOTEST* Rapid Urease Test

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
LYR	Helicobacter pylori	Microbiology	866.3110	1

GMDN Terms

Code	Name	Definition	Implantable	Status
52787	Helicobacter pylori urease IVD, kit, chromogenic	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Helicobacter pylori bacteria urease enzyme in a clinical specimen, using a chromogenic test method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00350770927459	GS1
Unit of Use	10350770927456	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K882199	000