FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594168353
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN7AVPEC6
Catalog number
SAN7AVPEC6
Device description
VASCULAR PACK
Published
2021-06-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OEDAntimicrobial blood pressure cuff

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEDAntimicrobial Blood Pressure CuffCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594168351PackageGS12In Commercial Distribution
10195594168353PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559416835150195594168351
1019559416835310195594168353

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic surgical procedure kit, non-medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials intended to be used to assist a range of cardiothoracic surgical procedures; it does not contain pharmaceuticals. 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20884838114863NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-04-01
00884838114807NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-04-01
00884838114869NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-04-01
20884838114825NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
20884838114832NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
20884838114849NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
20884838114856NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
00884838114722NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
00884838114739NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
00884838114746NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
00884838114753NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
00884838114760NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
00884838114777NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
00884838114784NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
00884838114791NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
00884838009066NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
00884838009080NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
00884838009103NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
00884838009127NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
20884838114818NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-14
00884838009042NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-14
50195594168351CARDINAL HEALTHCardinal Health 200, LLCOED2021-06-16
20884838009022NIBP CuffsPhilips Medical Systems HsgOED2021-05-10
20884838009145NIBP CuffsPhilips Medical Systems HsgOED2021-05-10
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