FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956110816
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
15-0798E
Catalog number
15-0798E
Device description
TRACH CARE TRAY
Published
2025-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
50198956110814PackageGS120In Commercial Distribution
10198956110816PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895611081450198956110814
1019895611081610198956110816

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.

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253048049Kendall924492442026-06-15
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253047943Kendall92319231-2026-05-12
10192253047950Kendall923292322026-05-12
10192253048087Kendall93519351-2024-03-04
10192253048094Kendall93549354-2024-03-04
10192253048100Kendall93559355-2024-03-04
10192253048117Kendall93569356-2024-03-04
10192253047967Kendall92339233-2026-05-26
10198956361003CARDINAL HEALTHSOTOCURGRBSOTOCURGRB2026-08-18
10198956366107CARDINAL HEALTH34-2285H34-2285H2026-08-18
10198956381100CARDINAL HEALTH34-7731C34-7731C2026-08-18
10198956463738CARDINAL HEALTHPE23EANLDPE23EANLD2026-08-18
10198956469990CARDINAL HEALTHSNE54LCDECSNE54LCDEC2026-08-18
10198956502512CARDINAL HEALTHSCVDHAPMCLSCVDHAPMCL2026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956196186CARDINAL HEALTHCardinal Health 200, LLCNXA2025-10-16
10198956173842CARDINAL HEALTHCardinal Health 200, LLCNXA2025-08-22
50198956173840CARDINAL HEALTHCardinal Health 200, LLCNXA2025-08-22
10198459480379MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.NXA2025-08-18
40198459480370MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.NXA2025-08-18
50198956110814CARDINAL HEALTHCardinal Health 200, LLCNXA2025-06-26
10198459359217MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.NXA2025-06-02
40198459359218MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.NXA2025-06-02
10198459324130Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2025-04-18
40198459324131Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2025-04-18
10198459295102Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2025-03-16
40198459295103Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2025-03-16
10197106964163CARDINAL HEALTHCardinal Health 200, LLCNXA2025-03-06
50197106964161CARDINAL HEALTHCardinal Health 200, LLCNXA2025-03-06
10198459276743Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2025-03-02
10653160998846Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.NXA2025-03-02
40198459276744Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2025-03-02
40653160998847Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.NXA2025-03-02
10198459241659Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2025-01-19
10198459194214Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2024-12-01
40198459194215Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2024-12-01
10653160998006Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.NXA2024-10-13
40653160998007Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.NXA2024-10-13
10198459140839Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2024-10-06
40198459140830Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2024-10-06
10197106676844CARDINAL HEALTHCardinal Health 200, LLCNXA2024-09-26
50197106676842CARDINAL HEALTHCardinal Health 200, LLCNXA2024-09-26
10198459062438Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2024-08-06
40198459062439Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2024-08-06
10195327609306Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2024-07-29