Specimen Collection Swab

Basic Information

• Brand Name: Specimen Collection Swab
• Primary DI: 00810050852166
• Version / Model: SW0202X80
• Company Name: TYPENEX MEDICAL LLC
• Labeler DUNS: 600850213
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-11
• Public Version: 3
• Public Version Date: 2024-01-01
• Public Version Status: Update
• Public Device Record Key: 7fc290c2-6c4f-4d04-bb41-551bec61dbd1
• Distribution End Date: 2023-12-31

Device Description

Oropharyngeal Swab

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: Yes
• 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	00810050852180	GS1	Case	100	Not in Commercial Distribution	2023-12-31
Primary	00810050852166	GS1
Package	10810050852187	GS1	Shipping Carton	10	Not in Commercial Distribution	2023-12-31