FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439853061
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN11CLHH6
Catalog number
SAN11CLHH6
Device description
HHC CENTRAL LINE
Published
2020-07-10
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
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
50888439853061PackageGS16In Commercial Distribution
10888439853063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843985306150888439853061
1088843985306310888439853063

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 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
10192253004649Monoject8602RC8602RC2026-07-09
10192253004656Monoject8605RC8605RC2026-07-09
10192253004663Monoject8607RC8607RC2026-07-09
10192253004700Monoject8617RC8617RC2026-07-09
10192253051575Precision2650SA2650SA2026-07-09
10197106896327CARDINAL HEALTHSNENU0868BSNENU0868B2026-07-09
10198956074668CARDINAL HEALTHSBA37OTMOFSBA37OTMOF2026-07-09
10198956119260CARDINAL HEALTHSBA69MPSUBSBA69MPSUB2026-07-09
10198956119437CARDINAL HEALTHPVVMVPBLGPVVMVPBLG2026-07-09
10198956255586CARDINAL HEALTHSOP53SAPTHSOP53SAPTH2026-07-09
10198956268272CARDINAL HEALTHSMA54CSWMMSMA54CSWMM2026-07-09
10198956286719CARDINAL HEALTHSOT11BR10MSOT11BR10M2026-07-09
10198956307308CARDINAL HEALTHSAN43ADSWOSAN43ADSWO2026-07-09
10198956313576CARDINAL HEALTHSMA69BTDNBSMA69BTDNB2026-07-09
10198956333888CARDINAL HEALTHPBCGLSARGPBCGLSARG2026-07-09
10198956334373CARDINAL HEALTHSNECGBPNODSNECGBPNOD2026-07-09
10198956339132CARDINAL HEALTHSEYHDCAGWHSEYHDCAGWH2026-07-09
10198956345942CARDINAL HEALTHSANOCIRHTBSANOCIRHTB2026-07-09
10198956349834CARDINAL HEALTHSAN73PLCHMSAN73PLCHM2026-07-09
10198956360358CARDINAL HEALTHSCV73VPBHDSCV73VPBHD2026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10193489399912Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2022-12-25
10193489399936Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2022-12-25
10193489482164Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2022-08-04