FDA.reportPublic FDA data

MEDI

Primary DI
00636257204849
Brand
MEDI
Company
MEDI MANUFACTURING, INC.
Model
DP1AU75
Device description
!DO HERNIA SUPPORT BELT WHITE SIZE 2X
Published
2025-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IQEORTHOSIS, LUMBAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQEOrthosis, LumbarPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00636257204849PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00636257204849006362572048496362572048490636257204849

GMDN Terms#

Term, Definition table
TermDefinition
Intestinal stoma shield/support belt, single-useA non-sterile plate, typically with a waist belt for attachment, intended to be placed over an enteric stoma (surgically-created artificial opening between the intestines and the body surface through which bodily waste is drained) to protect it from harmful external influences (e.g., knocks, friction), to reduce the risk of stomal herniation, or to help maintain adhesion of the base plate to the skin. Also known as a stoma protector it is usually attached by the patient to the base plate/wafer that retains the stomal bag, or might be placed directly over the stomal opening when the bag is removed; it may in addition include an attachable ostomy bag protector. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-6334info@mediusa.com

Regulatory Flags#

DUNS number
960754430
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00636257215913MEDIDW51L522026-08-21
00636257215920MEDIDW51L532026-08-21
00636257215937MEDIDW51L542026-08-21
00636257215944MEDIDW51R522026-08-21
00636257215951MEDIDW51R532026-08-21
00636257215968MEDIDW51R542026-08-21
04068903520939MEDIK2102512026-08-21
04068903520946MEDIK2102522026-08-21
04068903520953MEDIK2102532026-08-21
04068903520960MEDIK2102542026-08-21
04068903520977MEDIK2102552026-08-21
00400000326986MEDISTS04352026-07-20
00400000326993MEDISTS04372026-07-20
00400000327006MEDISTS04392026-07-20
00400000327013MEDISTS04412026-07-20
00400000327020MEDISTS04432026-07-20
00400000327037MEDISTS04452026-07-20
00400000327044MEDISTS04472026-07-20
00400000327051MEDISTS05352026-07-20
00400000327068MEDISTS05372026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810179882211CopperFitIdeavillage Products CorpIQE2026-10-01
00810179882228CopperFitIdeavillage Products CorpIQE2026-10-01
00810179882235CopperFitIdeavillage Products CorpIQE2026-10-01
00810179882242CopperFitIdeavillage Products CorpIQE2026-10-01
00810179882259CopperFitIdeavillage Products CorpIQE2026-10-01
00810179882402CopperFitIdeavillage Products CorpIQE2026-10-01
04068903520939MEDIMEDI MANUFACTURING, INC.IQE2026-08-21
04068903520946MEDIMEDI MANUFACTURING, INC.IQE2026-08-21
04068903520953MEDIMEDI MANUFACTURING, INC.IQE2026-08-21
04068903520960MEDIMEDI MANUFACTURING, INC.IQE2026-08-21
04068903520977MEDIMEDI MANUFACTURING, INC.IQE2026-08-21
06979144490449Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-20
06979144490456Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-20
06979144490463Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-20
06979144490470Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-20
06979144490487Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-20
00810178889648CoreTechVIVE HEALTH LLCIQE2026-08-19
06979144490241Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490258Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490265Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490272Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490289Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490296Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490302Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490319Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490326Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490333Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490340Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490357Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490364Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18