FDA.report

Kendall

Primary DI
20884521175768
Brand
Kendall
Company
Cardinal Health, Inc.
Model
6642WF
Catalog number
6642WF
Device description
Window Transparent Film Dressing,Moisture Vapor Permeable
Published
2018-06-30
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
KGXTape and bandage, adhesive

Product Code Classifications

CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20884521175768PackageGS110In Commercial Distribution
30884521175765PackageGS180In Commercial Distribution
10884521175761PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088452117576820884521175768
3088452117576530884521175765
1088452117576110884521175761

GMDN Terms

TermDefinition
Synthetic polymer semi-permeable film dressing, adhesiveA transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue intended to provide protection (e.g., from dirt, water) and/or promote healing. It is a thin, clear film made of synthetic polymer material that is covered on one side with a pressure-sensitive adhesive. It may be applied directly to tissue or used in combination with other dressings (e.g., gauze) to protect postsurgical incisions and minor wounds (e.g., cuts, scrapes, burns, skin tears, blisters). It may also be used to secure to skin other devices such as vascular catheters, infusion ports, or tubing. This is a single-use device.

Device Sizes

TypeValueUnit
Length8Inch
Width6Inch

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
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 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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