FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594672843
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
15A0114B
Catalog number
15A0114B
Device description
PEDS TRACH CARE KIT
Published
2022-06-15
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
50195594672841PackageGS120In Commercial Distribution
10195594672843PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559467284150195594672841
1019559467284310195594672843

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

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
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
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
10198956110816CARDINAL HEALTHCardinal Health 200, LLCNXA2025-06-26
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