FDA.reportPublic FDA data

Kendall

Primary DI
30884521020942
Brand
Kendall
Company
Cardinal Health, Inc.
Model
55588B
Catalog number
55588B
Device description
Hydrophilic Foam Island Dressing,6 inch x 6 inch (15.2 cm x 15.2 cm) Pad
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
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
20884521020945PackageGS110In Commercial Distribution
30884521020942PackageGS150In Commercial Distribution
10884521020948PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452102094520884521020945
3088452102094230884521020942
1088452102094810884521020948

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
Length6Inch
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
true
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

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Primary DI, Brand, Company table
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07333350625993Mepore®Mölnlycke Health Care ABNAC2026-05-23
00361554003412Silicone Superabsorbent Bordered DressingGentell, LLCNAC2026-05-19
00361554003436Silicone Superabsorbent Bordered DressingGentell, LLCNAC2026-05-19
00361554003450Silicone Superabsorbent Bordered DressingGentell, LLCNAC2026-05-19
20197344025340MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-03-13
30197344016840MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-03-06
30197344016857MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-03-06
07333350045845Mepilex® TransferMölnlycke Health Care ABNAC2026-02-26
07333350416249Mepilex® TransferMölnlycke Health Care ABNAC2026-02-26
20665973033024DukalDukal LLCNAC2026-02-26
00197998275326Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00197998275951Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
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00197998276071Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
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00197998276316Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00810178883646ViveCareVIVE HEALTH LLCNAC2026-02-05
00810178883653ViveCareVIVE HEALTH LLCNAC2026-02-05
00810178883660ViveCareVIVE HEALTH LLCNAC2026-02-05
00810178883677ViveCareVIVE HEALTH LLCNAC2026-02-05
20197344016812MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-02-05
20197344016836MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-02-05
00198926007453OrchidQuest USA Corp.NAC2026-02-03
00198926007460OrchidQuest USA Corp.NAC2026-02-03