FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594000370
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
15-6759C
Catalog number
15-6759C
Device description
TRACHEOSTOMY CARE
Published
2021-04-13
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
50195594000378PackageGS136In Commercial Distribution
10195594000370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559400037850195594000378
1019559400037010195594000370

GMDN Terms#

Term, Definition table
TermDefinition
Intrathecal anaesthesia set, medicatedA collection of devices intended for the single-administration of an analgesic or anaesthetic agent to the intrathecal space for the management of pain (known as spinal block, subarachnoid block, or intradural block). It includes the pharmaceutical anaesthetic agent, spinal needle and a syringe, with additional devices utilized for the procedure (e.g., dressings). It is not intended for epidural anaesthesia. 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
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

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