FDA.report

Kendall

Primary DI
10884521084643
Brand
Kendall
Company
Cardinal Health, Inc.
Model
4582BC
Catalog number
4582BC
Device description
Cohesive Bandage,Blue,Stretched
Published
2018-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
10884521084643PackageGS136In Commercial Distribution
20884521084640PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088452108464310884521084643
2088452108464020884521084640

GMDN Terms

TermDefinition
Adhesive bandageA sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Width2Inch

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00This side up;

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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
20884521014937Monoject888151111088815111102016-09-24
20884521014944Monoject888151113688815111362016-09-24
20884521025674Dover888473259888847325982016-09-24
20884527021434Kendall33503335032016-09-24
20884527021441Kendall33504335042016-09-24
20884527021458Kendall33505335052016-09-24
20884527021465Kendall33506335062016-09-24
20884527021472Kendall33507335072016-09-24
20884527021489Kendall33508335082016-09-24
20884527021502Kendall33510335102016-09-24
30884521012442Monoject888120231488812023142018-06-27
20884521012469Monoject888120232288812023222018-06-27
30884521012473Monoject888120233088812023302018-06-27
30884521012497Monoject888120234888812023482018-06-27
30884521012534Monoject888120237188812023712018-06-30
30884521012558Monoject888120238988812023892018-06-27
20884521012568Monoject888120239788812023972018-06-30
20884521142760Monoject10884521142763108845211427632018-06-29
00029369211032MCDAVIDMH794002112023-05-26
90884521162088Uni-PatchMH73912MH739122018-06-30

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