HidraWear

Primary DI
05391535510030
Brand
HidraWear
Company
HIDRAMED SOLUTIONS LIMITED
Model
GAX001-04
Device description
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: Extra Large
Published
2022-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDRBinder, Medical, Therapeutic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDRBinder, Medical, TherapeuticGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391535510030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391535510030053915355100305391535510030

GMDN Terms#

Term, Definition table
TermDefinition
Non-adhesive device retention bandageA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+3530873361512info@hidrawear.com

Regulatory Flags#

DUNS number
985651636
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391535510184HidraWearGAX002-012022-12-20
05391535510191HidraWearGAX002-022022-12-20
05391535510207HidraWearGAX002-032022-12-20
05391535510214HidraWearGAX002-042022-12-20
05391535510221HidraWearGAX002-052022-12-20
05391535510283HidraWearGBB001-012022-12-20
05391535510290HidraWearGBB001-022022-12-20
05391535510306HidraWearGBB001-032022-12-20
05391535510313HidraWearGBB001-042022-12-20
05391535510320HidraWearGBB001-052022-12-20
05391535510382HidraWearGBB002-012022-12-20
05391535510399HidraWearGBB002-022022-12-20
05391535510405HidraWearGBB002-032022-12-20
05391535510412HidraWearGBB002-042022-12-20
05391535510429HidraWearGBB002-052022-12-20
05391535510009HidraWearGAX001-012022-11-29
05391535510016HidraWearGAX001-022022-11-29
05391535510023HidraWearGAX001-032022-11-29
05391535510092HidraWearGAX001-052022-11-29

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