FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106553655
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
19-3947C
Catalog number
19-3947C
Device description
CENTRAL LINE KIT
Published
2024-04-10
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
PEZCentral venous catheter dressing change kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEZCentral Venous Catheter Dressing Change KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106553655PackageGS148In Commercial Distribution
10197106553657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710655365550197106553655
1019710655365710197106553657

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 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
20192253019992Kendall33547T33547T--2026-05-26
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
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25
10198956354517CARDINAL HEALTHSOP44TSTODSOP44TSTOD2026-05-25
10198956358003CARDINAL HEALTHSOT53CYPZDSOT53CYPZD2026-05-25
10198956358904CARDINAL HEALTHSOP53ACVLFSOP53ACVLF2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50198956390322CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-03-23
50198956412161CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-03-23
50198956348330CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-03-19
50198956391862CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-03-19
50198956408799CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-03-10
20809160515195Clear SequenceMEDICAL ACTION INDUSTRIES INC.PEZ2026-03-06
20809160514990Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEZ2026-03-04
50198956372885CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-03-02
20809160513924MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PEZ2026-02-25
50198956348323CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-02-23
50198956339116CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-02-13
20809160512521MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PEZ2026-02-13
20809160512231MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PEZ2026-02-11
20809160512248MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PEZ2026-02-11
20809160512262MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PEZ2026-02-11
20809160511852MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PEZ2026-02-09
50198956339987CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-02-02
50198956322347CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-01-29
20809160510541MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PEZ2026-01-29
20809160508609Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEZ2026-01-13
20809160507619Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEZ2026-01-06
50198956269512CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-01-05
20809160507206Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEZ2025-12-22
50198956269352CARDINAL HEALTHCardinal Health 200, LLCPEZ2025-12-19
20809160506858Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEZ2025-12-18
50198956236927CARDINAL HEALTHCardinal Health 200, LLCPEZ2025-12-17
20809160505844Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEZ2025-12-09
20809160505905Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEZ2025-12-09
20809160505578MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PEZ2025-12-04
20809160505356Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEZ2025-12-02