FDA.report

Kendall

Primary DI
00884521065409
Brand
Kendall
Company
Cardinal Health, Inc.
Model
55511AMD
Catalog number
55511AMD
Device description
AMD Antimicrobial Fenestrated Foam Disc Dressing,0.5% Polyhexamethylene Biguanide HCI (PHMB)
Published
2018-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FRODressing, wound, drug

Product Code Classifications

CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00884521065386PackageGS110In Commercial Distribution
00884521065409PackageGS140In Commercial Distribution
10884521065383PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00884521065386008845210653868845210653860884521065386
00884521065409008845210654098845210654090884521065409
1088452106538310884521065383

GMDN Terms

TermDefinition
Wound-nonadherent dressing, absorbent, non-antimicrobialA wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device.

Device Sizes

TypeValueUnit
Outer Diameter0.125Inch
Outer Diameter1Inch

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep dry;AVOID DIRECT SUNLIGHT

Sterilization Methods

Method

Regulatory Flags

DUNS number
080935429
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
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
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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