AccessGUDID - DEVICE: HidraWear (05391535510221)

GUDID

Device Identifier (DI) Information

Brand Name: HidraWear
Version or Model: GAX002-05
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HIDRAMED SOLUTIONS LIMITED

Primary DI Number: 05391535510221
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 985651636 *Terms of Use

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 Extra Large

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDR	Binder, Medical, Therapeutic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2b0c9bf3-99af-4dd2-b2f3-4dbf7caa78ce
Public Version Date: December 28, 2022
Public Version Number: 1
DI Record Publish Date: December 20, 2022