FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594225795
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
15-0585B
Catalog number
15-0585B
Device description
MINI TRACH CARE KIT
Published
2021-10-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NXATracheotomy care kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NXATracheotomy Care KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594225795PackageGS150In Commercial Distribution
10195594225797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559422579550195594225795
1019559422579710195594225797

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy care kit, single-useA collection of sterile devices and supplies intended to be used for the maintenance of a tracheostomy (i.e., removal and cleaning of tracheostomy tube prior to reinsertion). It typically includes towels, gauze, swabs, cleaning brush, and gloves. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50198956173840CARDINAL HEALTHCardinal Health 200, LLCNXA2025-08-22
40198459480370MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.NXA2025-08-18
50198956110814CARDINAL HEALTHCardinal Health 200, LLCNXA2025-06-26
40198459359218MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.NXA2025-06-02
40198459324131Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2025-04-18
40198459295103Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2025-03-16
50197106964161CARDINAL HEALTHCardinal Health 200, LLCNXA2025-03-06
40198459276744Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2025-03-02
40653160998847Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.NXA2025-03-02
40198459194215Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2024-12-01
40653160998007Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.NXA2024-10-13
40198459140830Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2024-10-06
50197106676842CARDINAL HEALTHCardinal Health 200, LLCNXA2024-09-26
40198459062439Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2024-08-06
40195327609307Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2024-07-29
40198459014384Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2024-07-29
40198459020828Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2024-07-29
40653160997307Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.NXA2024-06-23
50197106486069CARDINAL HEALTHCardinal Health 200, LLCNXA2024-06-10
50197106634828CARDINAL HEALTHCardinal Health 200, LLCNXA2024-05-22
50197106455430CARDINAL HEALTHCardinal Health 200, LLCNXA2024-03-01
40195327611522Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2024-02-05
40195327596324Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2024-01-07
40195327465040Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2023-12-21
40195327467266Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2023-12-21
40195327492626Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2023-12-21
40653160995716Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.NXA2023-12-21
50197106479986CARDINAL HEALTHCardinal Health 200, LLCNXA2023-11-09
40195327534142Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2023-10-29
40653160995976Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.NXA2023-10-15