Aptima Unisex Specimen Collection Swab

Basic Information

• Brand Name: Aptima Unisex Specimen Collection Swab
• Primary DI: 00862255000347
• Version / Model: CD215
• Catalog Number: CD215
• Company Name: Mml Diagnostics Packaging, Inc.
• Labeler DUNS: 046262341
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-10
• Public Version: 1
• Public Version Date: 2022-11-18
• Public Version Status: New
• Public Device Record Key: b1c68407-df91-476b-9974-218710a50074

Device Description

The MML Specimen Collection Swab is an absorbent polyester-tipped applicator intended for medical purposes that consists of an absorbent polyester swab bud adhered to a plastic shaft. The single use device is intended to collect a specimen from a patient. The MML Specimen Collection Swab is a Class 1 sterile device. Note: MML’s customers purchase this swab to be a component of their specimen collection/testing kits, as specified by the customer. This swab is only distributed as a component of a customer’s collection/testing kit and is not sold or distributed as a stand-alone device. The MML Specimen Collection Swab is intended to be used for the collection of a broad spectrum of specimens including human clinical specimens, as defined by the customer’s specific collection kit.

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
33722	General-purpose absorbent tip applicator/swab, single-use	A hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00862255000347	GS1

Customer Contacts

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