FDA.report

Curity

Primary DI
20192253046905
Brand
Curity
Company
Cardinal Health 200, LLC
Model
6121
Catalog number
6121-
Device description
Curity Non-adherent Strips
Published
2023-11-03
Public version status
New
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

Product Codes

CodeName
KMFBandage, liquid

Product Code Classifications

CodeDeviceSpecialtyClass
KMFBandage, LiquidGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20192253046905PackageGS125In Commercial Distribution
50192253046906PackageGS14In Commercial Distribution
10192253046908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019225304690520192253046905
5019225304690650192253046906
1019225304690810192253046908

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
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

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10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
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10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

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20192253048114KendallCardinal Health 200, LLCKMF2024-03-04
20192253046868CurityCardinal Health 200, LLCKMF2023-10-25
20192253046882CurityCardinal Health 200, LLCKMF2023-10-25
30192253046872CurityCardinal Health 200, LLCKMF2023-10-25
20192253046844CurityCardinal Health 200, LLCKMF2023-10-24
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