FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956623422
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN35CIB10
Catalog number
SAN35CIB10
Device description
BJC CVC INSERTION KIT
Published
2026-10-26
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
OFFCentral venous catheter tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFFCentral Venous Catheter TrayCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956623420PackageGS14In Commercial Distribution
10198956623422PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895662342050198956623420
1019895662342210198956623422

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic surgical procedure kit, medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials including a pharmaceutical component, intended to be used to assist a range of cardiothoracic surgical procedures. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. This is a single-use device intended to be sterilized prior to use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

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
00885380173700Curity1806G1806G2026-10-26
10192253010015Kangaroo7761507761502026-10-26
10198956294127CARDINAL HEALTHSOPHDTHWWCSOPHDTHWWC2026-10-26
10198956515376CARDINAL HEALTHSBA69FFKWRSBA69FFKWR2026-10-26
10198956516342CARDINAL HEALTHSMA54GLPOISMA54GLPOI2026-10-26
10198956519138CARDINAL HEALTHSMA55CPYKFSMA55CPYKF2026-10-26
10198956542006CARDINAL HEALTH20-485AI20-485AI2026-10-26
10198956555839CARDINAL HEALTHAMN696315EAMN696315E2026-10-26
10198956562905CARDINAL HEALTHSEY57KC00GSEY57KC00G2026-10-26
10198956565784CARDINAL HEALTHSNEOCSPSBCSNEOCSPSBC2026-10-26
10198956566705CARDINAL HEALTHPN41LMLAKPN41LMLAK2026-10-26
10198956568884CARDINAL HEALTH27-9143M27-9143M2026-10-26
10198956573437CARDINAL HEALTHSAN12AIUVFSAN12AIUVF2026-10-26
10198956575028CARDINAL HEALTHSMA73UGKSISMA73UGKSI2026-10-26
10198956576940CARDINAL HEALTHSOP69SH45CSOP69SH45C2026-10-26
10198956577107CARDINAL HEALTHSEN4AEAJHWSEN4AEAJHW2026-10-26
10198956577282CARDINAL HEALTHSBAOCMBKCRSBAOCMBKCR2026-10-26
10198956578869CARDINAL HEALTHSBAOCMJWYJSBAOCMJWYJ2026-10-26
10198956590359CARDINAL HEALTHSBA4QFLFPCSBA4QFLFPC2026-10-26
10198956591981CARDINAL HEALTHSOP69EEKRESOP69EEKRE2026-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956573437CARDINAL HEALTHCardinal Health 200, LLCOFF2026-10-26
10198956573338CARDINAL HEALTHCardinal Health 200, LLCOFF2026-09-22
10809160527078MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OFF2026-07-14
10198956525672CARDINAL HEALTHCardinal Health 200, LLCOFF2026-07-06
10193489413670Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-07-29
10193489212143Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489212655Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489215205Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489376364Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489382747Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489409420Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489411232Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489412826Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489412918Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489416534Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489420210Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489421569Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489421675Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489421774Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489422061Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489433135Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489452396Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489452471Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489452846Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489456028Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489377194Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-01-01
10193489377354Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-01-01
10193489422689Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-01-01
10193489423099Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-01-01
10193489423105Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-01-01