WM Nasopharyngeal Swab

Basic Information

• Brand Name: WM Nasopharyngeal Swab
• Primary DI: D040702031
• Version / Model: 70203
• Catalog Number: 70203
• Company Name: WHIP-MIX CORPORATION
• Labeler DUNS: 006385173
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-21
• Public Version: 3
• Public Version Date: 2021-08-26
• Public Version Status: Update
• Public Device Record Key: 39d6c342-14e8-4577-8732-5b61fdba6ddb
• Distribution End Date: 2021-02-24

Device Description

Whip Mix Nasopharyngeal Swab is a 3D printed device designed to collect test samples from patient.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
Primary	D040702031	HIBCC