FDA.reportPublic FDA data

iMed Technology Anchor Dry 12x14

Primary DI
00850010866123
Brand
iMed Technology Anchor Dry 12x14
Company
Imed Technology, Inc.
Model
iMed 12x14
Device description
iMed Anchor Dry 12x14 Master Carton
Published
2024-12-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850010866130PrimaryGS10
00850010866147PrimaryGS10
00850010866123Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850010866130008500108661308500108661300850010866130
00850010866147008500108661478500108661470850010866147
00850010866123008500108661238500108661230850010866123

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic polymer semi-permeable film dressing, adhesiveA transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue intended to provide protection (e.g., from dirt, water) and/or promote healing. It is a thin, clear film made of synthetic polymer material that is covered on one side with a pressure-sensitive adhesive. It may be applied directly to tissue or used in combination with other dressings (e.g., gauze) to protect postsurgical incisions and minor wounds (e.g., cuts, scrapes, burns, skin tears, blisters). It may also be used to secure to skin other devices such as vascular catheters, infusion ports, or tubing. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
087974775
Device count
490
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850010866014iMed Technology Anchor Dry 5x5iMed 5x52025-03-25
00850010866017iMed Technology Anchor Dry 5x5iMed 5x52024-12-28
00850010866048iMed Technology Anchor Dry 7x7iMed 7x72024-12-28
00850010866055iMed Technology Anchor Dry 7x7iMed 7x72024-12-28
00850010866079iMed Technology Anchor Dry 9x9iMed 9x92024-12-28
00850010866086iMed Technology Anchor Dry 9x9iMed 9x92024-12-28
00850010866109iMed Technology Anchor Dry 10x12iMed 10x122024-12-28
00850010866116iMed Technology Anchor Dry 10x12iMed 10x122024-12-28
00850010866130iMed Technology Anchor Dry 12x14iMed 12x142024-12-28
00850010866147iMed Technology Anchor Dry 12x14iMed 12x142024-12-28
00850010866000iMed Technology Anchor Dry 5x5iMed 5x52024-12-28
00850010866031iMed Technology Anchor Dry 7x7iMed 7x72024-12-28
00850010866062iMed Technology Anchor Dry 9x9iMed 9x92024-12-28
00850010866093iMed Technology Anchor Dry 10x12iMed 10x122024-12-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850088144598CARBOUNingbo kehu Medical Technology Co.,Ltd.KGX2026-07-10
00850088144642CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-10
00850088144659CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-10
00850088144697CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-10
00850088144215CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144222CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144239CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144246CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144253CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144000CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-03
00850088144017CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-03
00850088144093CARBOUNingbo kehu Medical Technology Co.,Ltd.KGX2026-07-01
00850087488686CeeportCEEPORT INC.NAD2026-06-30
14931921902902BLUPRO Attachment TapeNIHON KOHDEN CORPORATIONKGX2026-06-23
06970206823946Dr Perfect Hydrocolloid DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206823977kegel Hydrocolloid DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827067Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827074Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827081Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827098Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827104Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206828149Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206828156Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206828163Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206828170Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
00850087488556CeeportCEEPORT INC.KGX2026-06-12
16973405130119AODEJIANWenzhou Anqi Medical Supplies Co., LtdKGX2026-06-10
00049696189583THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00049696561228THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00049696677547THERA PlusFOURSTAR GROUP INC.KGX2026-06-09