FDA.reportPublic FDA data

Kendall

Primary DI
20884521177250
Brand
Kendall
Company
Cardinal Health, Inc.
Model
55523BAMDX
Catalog number
55523BAMDX
Device description
AMD Antimicrobial Foam Border Dressing,0.5% Polyhexamethylene Biguanide HCI (PHMB)
Published
2018-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, wound, drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521177250PackageGS110In Commercial Distribution
30884521177257PackageGS150In Commercial Distribution
10884521177253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452117725020884521177250
3088452117725730884521177257
1088452117725310884521177253

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, absorbent, antimicrobialA wound covering typically in the form of a multi-layered pad having a material on its skin-contact surface that prevents adherence to the wound bed (e.g., soft silicone), thereby decreasing the potential for wound trauma, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It is used to absorb blood and exudates from the wound, while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing with other wound-care products to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3.25Inch
Width1.75Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry;AVOID DIRECT SUNLIGHT

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080935429
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884527009954Kendall30781747307817472018-06-23
30884527004748Kendall5000736150007361-2016-09-24
10884521021105MonojectSC5008XSC5008X2016-10-20
10884521021112MonojectSC6011XSC6011X2016-10-20
20884521152066Devon31145660311456602016-09-24
20884521152073Devon31145678311456782016-09-24
20884521152080Devon31145686311456862016-09-24
20884521152097Devon31145694311456942016-09-24
20884521152103Devon31145702311457022016-09-24
20884521152110Devon31145710311457102016-09-24
20884521152127Devon31145728311457282016-09-24
20884527020529Argyle888816035888881603582016-09-28
10884521000711Argyle888875001888887500182016-09-24
10884521000735Argyle888875051388887505132016-09-24
10884521011502Kangaroo888474121288847412122016-09-24
10884521011519Kangaroo888474121588847412152016-09-24
10884521011526Kangaroo888474122088847412202016-10-20
10884521011533Kangaroo888474122588847412252016-09-24
10884521011557Kangaroo888474123588847412352016-09-24
10884521011595Kangaroo888474164988847416492016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00365197409105A+D Antimicrobial HydrogelSonoma Pharmaceuticals, Inc.FRO2026-05-25
00850087488006CeeportCEEPORT INC.FRO2026-05-22
10885632434266HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632468490HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632468506HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632468513HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632468520HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632509032HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632509049HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632509056HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632509063HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632510199HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
06977727072211Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072228Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072235Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072242Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072419SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072426SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072433SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072440SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
00050428339770CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-03-20
04719883980090Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980311Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980342Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980359Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980366Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980373Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980380Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980397Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
05060996770023AcutarexAlliance Healing Technologies, LLCFRO2026-03-13