HidraWear

Basic Information

• Brand Name: HidraWear
• Primary DI: 05391535510214
• Version / Model: GAX002-04
• Company Name: HIDRAMED SOLUTIONS LIMITED
• Labeler DUNS: 985651636
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-20
• Public Version: 1
• Public Version Date: 2022-12-28
• Public Version Status: New
• Public Device Record Key: 6a89272c-fd60-47e8-a561-710cdeb13b12

Device Description

The HidraWear AX T-shirt device is a garment device, which is intended for the retention of a dressing in the axillar area. The HidraMed AX T-shirt is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn under a shirt or in place of a regular t-shirt and then a dressing is applied to the axillar area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care. Size: Extra Large

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MDR	Binder, Medical, Therapeutic	General Hospital	880.5160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58964	Non-adhesive device retention bandage	A piece or roll of material intended to be wrapped around a part of the body to secure a device (e.g., skin dressing, catheter, cannula) to the patient, without adhering to or compressing the body. It may be made from a variety or combination of materials, including cotton, viscose, and plastic (e.g., polyamide), and some types are cohesive (i.e., the bandage adheres to itself but not to other surfaces); it is used in various clinical specialties (e.g., dermatology, general/plastic surgery). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05391535510214	GS1

Customer Contacts

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