FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956525672
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SANCGLAAC5
Catalog number
SANCGLAAC5
Device description
GEN LINE ACCESS PACK CMC
Published
2026-07-06
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
50198956525670PackageGS12In Commercial Distribution
10198956525672PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895652567050198956525670
1019895652567210198956525672

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
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04
10198956210240CARDINAL HEALTHAMN213116EAMN213116E2026-09-04
10198956310933CARDINAL HEALTHANE439532GANE439532G2026-09-04
10198956331891CARDINAL HEALTHSAN13ARBIFSAN13ARBIF2026-09-04
10198956333420CARDINAL HEALTHSANX4IPSSCSANX4IPSSC2026-09-04
10198956359291CARDINAL HEALTHSMA54BGEVCSMA54BGEVC2026-09-04
10198956379084CARDINAL HEALTHSOP33EXMSGSOP33EXMSG2026-09-04
10198956395947CARDINAL HEALTHSOPMIMPMSBSOPMIMPMSB2026-09-04
10198956398467CARDINAL HEALTHSBA44LPCEASBA44LPCEA2026-09-04
10198956415195CARDINAL HEALTHSCVCGOHILHSCVCGOHILH2026-09-04
10198956421462CARDINAL HEALTHSOPMVSAUCJSOPMVSAUCJ2026-09-04
10198956426061CARDINAL HEALTHSCVDKMVOGDSCVDKMVOGD2026-09-04
10198956428102CARDINAL HEALTHSAN13RDEMSSAN13RDEMS2026-09-04
10198956454989CARDINAL HEALTHSOP23KPNLCSOP23KPNLC2026-09-04
10198956462977CARDINAL HEALTHSBA48LCRHCSBA48LCRHC2026-09-04
10198956463394CARDINAL HEALTHSEN23TAPCLSEN23TAPCL2026-09-04
10198956464520CARDINAL HEALTHSMA23GPNVBSMA23GPNVB2026-09-04
10198956465510CARDINAL HEALTH34-3217C34-3217C2026-09-04
10198956468399CARDINAL HEALTHPO1DTHAMQPO1DTHAMQ2026-09-04
10198956468481CARDINAL HEALTHSMAOCGLSTGSMAOCGLSTG2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160527078MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OFF2026-07-14
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