FDA.report

Kendall

Primary DI
40884521025012
Brand
Kendall
Company
Cardinal Health, Inc.
Model
9243
Catalog number
9243
Device description
Calcium Alginate Dressing,Rope
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

Related Records

Contact Domains

Product Codes

CodeName
KMFBandage, liquid

Product Code Classifications

CodeDeviceSpecialtyClass
KMFBandage, LiquidGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30884521025015PackageGS15In Commercial Distribution
40884521025012PackageGS120In Commercial Distribution
10884521025011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3088452102501530884521025015
4088452102501240884521025012
1088452102501110884521025011

GMDN Terms

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

TypeValueUnit
Length24Inch

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep dry;AVOID DIRECT SUNLIGHT

Sterilization Methods

Method

Contacts

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 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 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
007073878098983M™ Cavilon™3M COMPANYKMF2023-09-22
007073878099113M™ Cavilon™3M COMPANYKMF2023-09-22
507073878094593M™ Cavilon™3M COMPANYKMF2023-06-08
507073878094733M™ Cavilon™3M COMPANYKMF2023-06-08
507073878094973M™ Cavilon™3M COMPANYKMF2023-06-08
507073878095103M™ Cavilon™3M COMPANYKMF2023-06-08
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