FDA.reportPublic FDA data

careGARD

Primary DI
00850003042190
Brand
careGARD
Company
Extremity Care
Model
EC002
Device description
"careGARD A Sterile Bordered Gauze Dressing Tape 4"" x 4"" Pad 2.5""X 2.5"" "
Published
2023-02-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850003042197PackageGS130Not in Commercial Distribution
00850003042190PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000304219710850003042197
00850003042190008500030421908500030421900850003042190

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2.5Inch
Width2.5Inch

Regulatory Flags#

DUNS number
086365085
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850003042169carePACECP-0302023-02-02
00850003042176carePACECD-0302023-02-02
00850003042183carePACECA-0302023-02-02
00850003042206careLAGENEC0042023-02-02
00850003042213KendallEC0072023-02-02
00850003042220careLAGENEC0082023-02-02
00850003042411carePACCS-MA01 2024-02-06
00850003042428carePACCS-PB012024-02-06
00850003042435carePACCS-MB012024-02-06
00850003042442carePACCS-PN012024-02-06
00850003042459carePACCS-MN012024-02-06
00850003042473carePACCX-MB012024-02-06
00850003042381Extremity CareALC4252024-02-06
00850003042398Extremity CareALC400S2024-02-06
00850003042404carePACCS-PA012024-02-06
00850003042466carePACCX-PB012024-02-06
00850003042329careLAGEN EC0112023-07-19
00850003042312Paper Surgical TapeEC0012023-04-21
00850003042305Extremity CareATL100S2023-03-30
00850003042237Extremity CareALC100S2023-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974692681561GUANGYIJiangsu Guangyi Medical Dressing Co.,LTD.NAC2026-07-22
01714196634404HydraLock SA with BorderSion Brands LLCNAC2026-07-16
01714196635500HydraLock SA with BorderSion Brands LLCNAC2026-07-16
01714196637702HydraLock SA with BorderSion Brands LLCNAC2026-07-16
10197344175963MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-07-13
10197344175970MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-07-13
10197344175987MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-07-13
00850088144314CARBOUNingbo kehu Medical Technology Co.,Ltd.NAC2026-07-08
00197344111513CURADMEDLINE INDUSTRIES, INC.NAC2026-07-03
00197998001727Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00197998295812Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00197998295850Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00197998295898Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00197998295942Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00810178889921ViveCareVIVE HEALTH LLCNAC2026-05-29
00810178889938ViveCareVIVE HEALTH LLCNAC2026-05-29
00810178889945ViveCareVIVE HEALTH LLCNAC2026-05-29
00850087488433CeeportCEEPORT INC.NAC2026-05-29
00850087488440CeeportCEEPORT INC.NAC2026-05-29
00850087488518CeeportCEEPORT INC.NAC2026-05-29
09551031940007DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940014DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940021DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940038DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940045DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940052DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940069DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940076DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940083DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940090DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22