HidraWear

GUDID 05391535510009

The HidraWear AX device is a garment device, which is intended for the retention of a dressing in the axillar area. The HidraMed AX is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn over a brassiere and is then 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: Small

HIDRAMED SOLUTIONS LIMITED

Non-adhesive device retention bandage

• Primary Device ID: 05391535510009
• NIH Device Record Key: 6bb3e2c4-ec72-4681-98ee-000a38b173bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HidraWear
• Version Model Number: GAX001-01
• Company DUNS: 985651636
• Company Name: HIDRAMED SOLUTIONS LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +3530873361512
• Email: info@hidrawear.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391535510009 [Primary]

FDA Product Code

• MDR: Binder, Medical, Therapeutic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-07
• Device Publish Date: 2022-11-29

On-Brand Devices [HidraWear]

• 05391535510092: The HidraWear AX device is a garment device, which is intended for the retention of a dressing i
• 05391535510030: The HidraWear AX device is a garment device, which is intended for the retention of a dressing i
• 05391535510023: The HidraWear AX device is a garment device, which is intended for the retention of a dressing i
• 05391535510016: The HidraWear AX device is a garment device, which is intended for the retention of a dressing i
• 05391535510009: The HidraWear AX device is a garment device, which is intended for the retention of a dressing i