FDA.reportPublic FDA data

CARDINAL HEALTH ESSENTIALS

Primary DI
00885380109839
Brand
CARDINAL HEALTH ESSENTIALS
Company
RGH ENTERPRISES
Model
ZDHC44B
Catalog number
ZDHC44B
Device description
"Sterile Latex-Free Hydrocolloid Dressing with Film Back and Beveled Edge 4"" x 4"""
Published
2019-05-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NADDressing, wound, occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885380109833PackageGS110In Commercial Distribution
50885380109834PackageGS120In Commercial Distribution
00885380109839PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088538010983320885380109833
5088538010983450885380109834
00885380109839008853801098398853801098390885380109839

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobialA wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
049735438
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888499000523RELIAMEDZGB235ZGB2352019-05-17
00888499000530RELIAMEDZGB410ZGB4102019-05-17
00888499000547RELIAMEDZGB414ZGB4142019-05-17
00888499000561RELIAMEDZGB44ZGB442019-05-17
00888499000578RELIAMEDZGB46ZGB462019-05-17
00888499000585RELIAMEDZGB48ZGB482019-05-17
00888499000592RELIAMEDZGB66ZGB662019-05-17
00888499000608RELIAMEDZGC44ZGC442019-05-17
00888499000615RELIAMEDZGC66ZGC662019-05-20
00888499000622RELIAMEDZGFB44ZGFB442019-05-17
10885380122712CARDINAL HEALTH ESSENTIALSZTDR02ZTDR022019-05-22
10885380122729CARDINAL HEALTH ESSENTIALSZTDR04ZTDR042019-05-22
10885380122736CARDINAL HEALTH ESSENTIALSZTDR06ZTDR062019-05-22
00885380122548CARDINAL HEALTH ESSENTIALSZTSC08ZTSC082019-04-22
00885380122555CARDINAL HEALTH ESSENTIALSZTPA05AZTPA05A2019-05-22
00885380122562CARDINAL HEALTH ESSENTIALSZTPL05AZTPL05A2019-05-22
00885380122579CARDINAL HEALTH ESSENTIALSZTCL05AZTCL05A2019-05-22
00885380122685CARDINAL HEALTH ESSENTIALSZTCL01AZTCL01A2019-05-22
00885380122692CARDINAL HEALTH ESSENTIALSZTCL02AZTCL02A2019-05-22
00885380122708CARDINAL HEALTH ESSENTIALSZTCL03AZTCL03A2019-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850087488686CeeportCEEPORT INC.NAD2026-06-30
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
10885632506000HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-06-05
10885632506017HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-06-05
10885632506024HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-06-05
00850087488280CeeportCEEPORT INC.NAD2026-05-29
00850087488297CeeportCEEPORT INC.NAD2026-05-29
00850087488365CeeportCEEPORT INC.NAD2026-05-29
00850087488372CeeportCEEPORT INC.NAD2026-05-29
00850087488396CeeportCEEPORT INC.NAD2026-05-29
00850087488402CeeportCEEPORT INC.NAD2026-05-29
00850087488419CeeportCEEPORT INC.NAD2026-05-29
00324357200457Zeni MedicalFocus Health Group, Inc.NAD2026-04-13