FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956550285
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN11DBMMB
Catalog number
SAN11DBMMB
Device description
DR B ANGIO PACK
Published
2026-09-04
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
OEQAngiography/angioplasty kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEQAngiography/Angioplasty KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956550283PackageGS13In Commercial Distribution
10198956550285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895655028350198956550283
1019895655028510198956550285

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
00884450501696Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-04
10198956428102CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956509320CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956532205CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956546646CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956555556CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956556331CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956561779CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956562530CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956563377CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956563476CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956564961CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956565142CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956569195CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956569874CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956570344CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956570351CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956571723CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956573536CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956574472CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956574489CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
00884450430118Merit Medical®Merit Medical Systems, Inc.OEQ2026-08-27
10198956504486CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-26
10198956514706CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-26
10198956523401CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-26
10198956537743CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-26
10198956547155CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-26
10198956549456CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-26
10198956560307CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-26
10198956562400CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-26