AfterSwim® Water Removal

Basic Information

• Brand Name: AfterSwim® Water Removal
• Primary DI: 00859911004016
• Version / Model: 530-SD
• Catalog Number: 530-SD
• Company Name: Bionix, LLC
• Labeler DUNS: 117844489
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2022-01-06
• Public Version: 3
• Public Version Date: 2023-10-04
• Public Version Status: Update
• Public Device Record Key: b8c05a1a-5c47-4f0b-9465-0cd7b5283d8b
• Distribution End Date: 2023-09-30

Device Description

AfterSwim Water Removal

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KXF	APPLICATOR, ABSORBENT TIPPED, NON-STERILE	General Hospital	880.6025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65343	Ear canal drying sponge	A hand-held absorbent wedge intended to be partially inserted into the external auditory canal of the ear to dry the canal by absorbing water accumulated from bathing, showering, swimming, or diving, typically to prevent canal inflammation associated with water exposure (otitis externa or Swimmer’s ear). It is made of a soft spongy material and typically has a flared design to prevent over insertion and eardrum damage. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10859911004013	GS1
Primary	00859911004016	GS1

Customer Contacts

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