Argyle

Basic Information

• Brand Name: Argyle
• Primary DI: 10192253024449
• Version / Model: 8884724500
• Catalog Number: 8884724500
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-14
• Public Version: 1
• Public Version Date: 2024-02-22
• Public Version Status: New
• Public Device Record Key: 1809bccd-18d8-47ae-98b5-bd9ed5b9ccca

Device Description

Specimen Trap

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
BYZ	TRAP, STERILE SPECIMEN	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58169	Oral/respiratory tract specimen container IVD, no additive/medium	An empty covered receptacle containing no additives or media intended to be used in the home and clinical settings for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, oropharyngeal, and/or lower respiratory tract specimen (e.g., sputum) [excluding breath specimen], for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50192253024447	GS1	CASE	50	In Commercial Distribution
Primary	10192253024449	GS1

Device Sizes

Type	Value	Unit	Text
Total Volume	40	Milliliter