FDA.reportPublic FDA data

Kendall

Primary DI
20884521024868
Brand
Kendall
Company
Cardinal Health, Inc.
Model
9239
Catalog number
9239
Device description
Calcium Alginate Dressing
Published
2018-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMFBandage, liquid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMFBandage, LiquidGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521024868PackageGS110In Commercial Distribution
30884521024865PackageGS150In Commercial Distribution
10884521024861PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452102486820884521024868
3088452102486530884521024865
1088452102486110884521024861

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Inch
Width6Inch

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
080935429
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
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
10192253047967KendallCardinal Health 200, LLCKMF2026-05-26
00858071004256Advanced Seal Wound Barrier, 1oz sprayKericure Inc.KMF2025-08-21
00860013046415TearRepairOptmed IncKMF2025-05-30
20888277719740MedlineMEDLINE INDUSTRIES, INC.KMF2024-03-05
20192253048084KendallCardinal Health 200, LLCKMF2024-03-04
20192253048091KendallCardinal Health 200, LLCKMF2024-03-04
20192253048107KendallCardinal Health 200, LLCKMF2024-03-04
20192253048114KendallCardinal Health 200, LLCKMF2024-03-04
20192253046905CurityCardinal Health 200, LLCKMF2023-11-03
20192253046868CurityCardinal Health 200, LLCKMF2023-10-25
20192253046882CurityCardinal Health 200, LLCKMF2023-10-25
30192253046872CurityCardinal Health 200, LLCKMF2023-10-25
20192253046844CurityCardinal Health 200, LLCKMF2023-10-24
20192253046851CurityCardinal Health 200, LLCKMF2023-10-24
007073878098123M™ Cavilon™3M COMPANYKMF2023-09-22
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507073878094733M™ Cavilon™3M COMPANYKMF2023-06-08
507073878094973M™ Cavilon™3M COMPANYKMF2023-06-08
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507073878095343M™ Cavilon™3M COMPANYKMF2023-06-08
507073878095583M™ Cavilon™3M COMPANYKMF2023-06-08
507073878095723M™ Cavilon™3M COMPANYKMF2023-06-08
507073878096023M™ Cavilon™3M COMPANYKMF2023-06-08
507073878096263M™ Cavilon™3M COMPANYKMF2023-06-08
507073878096403M™ Cavilon™3M COMPANYKMF2023-06-08
507073878096643M™ Cavilon™3M COMPANYKMF2023-06-08
507073878097253M™ Cavilon™3M COMPANYKMF2023-06-08
507073878097493M™ Cavilon™3M COMPANYKMF2023-06-08