FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956487505
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN23PMP40
Catalog number
SAN23PMP40
Device description
PACEMAKER PACK PWH
Published
2026-06-01
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
50198956487503PackageGS13In Commercial Distribution
10198956487505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895648750350198956487503
1019895648750510198956487505

GMDN Terms#

Term, Definition table
TermDefinition
Angiography kitA collection of sterile devices and equipment used to prepare a patient for the radiographic visualization of the arteries of a particular organ system or body part through the vascular injection of contrast media. It typically includes a combination of fluid/contrast media administration devices (e.g., tubing, manifold, stopcocks, and syringes) and/or dedicated angiography supportive devices (e.g., angiography drapes, covers, dressings); the angiography catheter is not included. This is a single-use device.

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
50192253071595CONVERTORS8184NA8184NA2026-06-02
50192253071601CONVERTORS8187N8187N2026-06-02
50192253071618CONVERTORS8188NC8188NC2026-06-02
50192253071625CONVERTORS8189N8189N2026-06-02
20192253005971CONVERTORSAT7004AT70042019-04-16
20192253017080Kendall31.3876.0431.3876.042023-03-16
50885380183001CARDINAL HEALTH50001218500012182023-08-11
50885380182998CARDINAL HEALTH50001217500012172023-08-11
10197106817643CARDINAL HEALTHSEYHBDPANBSEYHBDPANB2026-06-01
10198956004887CARDINAL HEALTHSBAHFRPASCSBAHFRPASC2026-06-01
10198956201804CARDINAL HEALTH32-0828C32-0828C2026-06-01
10198956209220CARDINAL HEALTHPG33GLVWBPG33GLVWB2026-06-01
10198956225992CARDINAL HEALTHSOP54PPUOBSOP54PPUOB2026-06-01
10198956245754CARDINAL HEALTHSBACGKTACFSBACGKTACF2026-06-01
10198956248908CARDINAL HEALTHSAN43CATOBSAN43CATOB2026-06-01
10198956269323CARDINAL HEALTHSOP4QSHCLBSOP4QSHCLB2026-06-01
10198956311282CARDINAL HEALTHSCV11VSJKJSCV11VSJKJ2026-06-01
10198956312043CARDINAL HEALTHPW30PSPRHPW30PSPRH2026-06-01
10198956314634CARDINAL HEALTHSBAMIFPACBSBAMIFPACB2026-06-01
10198956314894CARDINAL HEALTHSEN42HNAMDSEN42HNAMD2026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956428324CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956444355CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956460973CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956469037CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956471696CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956476240CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956477711CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956488977CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956489295CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956489561CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956490307CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956490420CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956491342CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956492493CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956492875CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956493544CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956494190CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
00884450474570Merit Medical®Merit Medical Systems, Inc.OEQ2026-05-29
00884450430057Merit Medical®Merit Medical Systems, Inc.OEQ2026-05-28
00884450487549Merit Medical®Merit Medical Systems, Inc.OEQ2026-05-28
10809160522035HALYARDAVID MEDICAL, INC.OEQ2026-05-27
10193489078114NAMICMEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489078213NAMICMEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489078220NAMICMEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489213430Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489410013Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489413458Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489423372Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489424003Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489425147Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08