FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106908790
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN11PMN17
Catalog number
SAN11PMN17
Device description
PACEMAKER PACK
Published
2025-01-02
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
OAAAid, visual, for nausea

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OAAAid, Visual, For NauseaUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106908790PackageGS15In Commercial Distribution
10197106908792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710690879050197106908790
1019710690879210197106908792

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
10198956182004CARDINAL HEALTHSOPCNEPBSFSOPCNEPBSF2026-07-06
10198956202320CARDINAL HEALTH34-9397L34-9397L2026-07-06
10198956261952CARDINAL HEALTH08-1780F08-1780F2026-07-06
10198956331235CARDINAL HEALTH32-7479R32-7479R2026-07-06
10198956358942CARDINAL HEALTHSEN4LTAGRCSEN4LTAGRC2026-07-06
10198956373068CARDINAL HEALTHSOP53HIOHCSOP53HIOHC2026-07-06
10198956373655CARDINAL HEALTHSANCGANMWCSANCGANMWC2026-07-06
10198956380615CARDINAL HEALTHENDDK4659DENDDK4659D2026-07-06
10198956381124CARDINAL HEALTH34-0950C34-0950C2026-07-06
10198956388789CARDINAL HEALTHSMA11DCWNFSMA11DCWNF2026-07-06
10198956389007CARDINAL HEALTHSEN35ENCFDSEN35ENCFD2026-07-06
10198956393424CARDINAL HEALTHSBADHLPNVCSBADHLPNVC2026-07-06
10198956397361CARDINAL HEALTHSAN29MY87ISAN29MY87I2026-07-06
10198956398689CARDINAL HEALTHSAN3MARCVCSAN3MARCVC2026-07-06
10198956407053CARDINAL HEALTHSOP69TJMSBSOP69TJMSB2026-07-06
10198956414693CARDINAL HEALTHSOP48TKLODSOP48TKLOD2026-07-06
10198956416079CARDINAL HEALTHPN11SF36DPN11SF36D2026-07-06
10198956416482CARDINAL HEALTHSAN11CC26CSAN11CC26C2026-07-06
10198956423077CARDINAL HEALTHPBCGDCBLIPBCGDCBLI2026-07-06
10198956427198CARDINAL HEALTHSBA13SMBTBSBA13SMBTB2026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956101845CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-10
10198956102095CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-10
10198956110205CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-10
50198956101843CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-10
50198956102093CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-10
50198956110203CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-10
10198956101296CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-05
10198956101418CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-05
50198956101294CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-05
50198956101416CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-05
10197106908792CARDINAL HEALTHCardinal Health 200, LLCOAA2025-01-02
10197106824443CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-23
10197106835340CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-23
50197106824441CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-23
50197106835348CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-23
10197106876275CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-20
10197106866498CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-11
50197106866496CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-11
10197106825150CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-06
50197106825158CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-06
10197106852248CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-04
10197106859025CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-04
50197106852246CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-04
50197106859023CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-04
10197106810248CARDINAL HEALTHCardinal Health 200, LLCOAA2024-11-25
50197106810246CARDINAL HEALTHCardinal Health 200, LLCOAA2024-11-25
10197106721049CARDINAL HEALTHCardinal Health 200, LLCOAA2024-11-15
50197106721047CARDINAL HEALTHCardinal Health 200, LLCOAA2024-11-15
10197106796108CARDINAL HEALTHCardinal Health 200, LLCOAA2024-11-13
10197106828106CARDINAL HEALTHCardinal Health 200, LLCOAA2024-11-13