FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885380179891
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
C15055-006
Catalog number
C15055-006
Device description
APPLICATOR COTTON TIP 6 NS
Published
2021-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
KXFAPPLICATOR, ABSORBENT TIPPED, NON-STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXFApplicator, Absorbent Tipped, Non-SterileGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885380179898PackageGS1100In Commercial Distribution
50885380179899PackageGS110In Commercial Distribution
10885380179891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088538017989820885380179898
5088538017989950885380179899
1088538017989110885380179891

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose absorbent tip applicator/swab, single-useA hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device.

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253004205Monoject1525SA1525SA2026-07-13
10192253004410Monoject8507MW8507MW2026-07-13
10192253004540Monoject8533SA8533SA2026-07-13
10192253004588Monoject8537MW8537MW2026-07-13
10192253004625SharpSafety8540SA8540SA2026-07-13
10192253004885Monoject8900MW8900MW2026-07-13
10192253005127Monoject8979MW8979MW2026-07-13
10192253005509Monoject8525Y8525Y2026-07-13
10192253071894Argyle47802478022026-07-13
20192253017455Kendall31469219314692192021-05-05
20192253017547Medi-Trace Cadence22550A22550A-2021-07-28
20192253017554Medi-Trace Cadence22550P22550P-2021-08-19
20192253017578Medi-Trace Cadence22550PC22550PC2021-07-29
20192253017585Medi-Trace Cadence22550R22550R-2021-07-29
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
20192253017622Medi-Trace Cadence22770P22770P2021-08-19
20192253017639Medi-Trace Cadence22770PC22770PC2021-07-29
20192253017721Kendall31319281313192812021-05-05
20192253018889Medi-Trace Cadence22770R22770R-2021-07-29
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10889483563267BALLARD™SUNMED, LLCKXF2026-01-12
10889483563281BALLARD™SUNMED, LLCKXF2026-01-12
10889483563311BALLARD™SUNMED, LLCKXF2026-01-12
10889483563335BALLARD™SUNMED, LLCKXF2026-01-12
10889483563359BALLARD™SUNMED, LLCKXF2026-01-12
07613327680720Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
07613327680737Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
07613327680744Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
07613327680751Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
10889483563274BALLARD™SUNMED, LLCKXF2025-11-17
10889483563298BALLARD™SUNMED, LLCKXF2025-11-17
10889483563328BALLARD™SUNMED, LLCKXF2025-11-17
10889483563342BALLARD™SUNMED, LLCKXF2025-11-17
10889483565520BALLARD™SUNMED, LLCKXF2025-11-17
10889483565537BALLARD™SUNMED, LLCKXF2025-11-17
10889483565544BALLARD™SUNMED, LLCKXF2025-11-17
M220761002Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KXF2025-09-11
D832600BA4001MAXAPPLICATOR IIPLASDENT CORPORATIONKXF2025-08-01
D832600BF4001MAXAPPLICATOR IIPLASDENT CORPORATIONKXF2025-08-01
D832600BR4001MAXAPPLICATOR IIPLASDENT CORPORATIONKXF2025-08-01
10840330701454ProCureTwin Med, LLCKXF2024-11-14
10840330701461ProCureTwin Med, LLCKXF2024-11-14
10840330701478ProCureTwin Med, LLCKXF2024-11-14
10840330701485ProCureTwin Med, LLCKXF2024-11-14
00616784430713"DynaSafety Cotton-Tipped Applicators in Sealed Vial,3"""Dynarex CorporationKXF2024-11-11
00087701406973Good NeighborU.S. COTTON, LLCKXF2024-07-30
00817522013377SwabezeKENTEC MEDICAL, INC.KXF2024-06-28
00817522013353SwabezeKENTEC MEDICAL, INC.KXF2024-06-27
00817522013360SwabezeKENTEC MEDICAL, INC.KXF2024-06-27
00817522013384SwabezeKENTEC MEDICAL, INC.KXF2024-06-27