FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106690437
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA35DCMHA
Catalog number
SMA35DCMHA
Device description
D AND C PACK
Published
2024-07-16
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
PKAExternal upper esophageal sphincter (UES) compression device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKAExternal Upper Esophageal Sphincter (Ues) Compression DeviceEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106690435PackageGS16In Commercial Distribution
10197106690437PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710669043550197106690435
1019710669043710197106690437

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, medicatedA collection of various sterile surgical instruments, dressings, pharmaceuticals, and materials intended to be used during obstetrical/gynaecological surgery; it is a general-purpose obstetrical/gynaecological surgical kit, and as such is not dedicated to a specific procedure. This is a single-use device.

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
10197106827376CARDINAL HEALTHCardinal Health 200, LLCPKA2024-12-18
50197106827374CARDINAL HEALTHCardinal Health 200, LLCPKA2024-12-18
10197106743171CARDINAL HEALTHCardinal Health 200, LLCPKA2024-09-26
50197106743179CARDINAL HEALTHCardinal Health 200, LLCPKA2024-09-26
50197106690435CARDINAL HEALTHCardinal Health 200, LLCPKA2024-07-16
10197106652015CARDINAL HEALTHCardinal Health 200, LLCPKA2024-06-15
50197106652013CARDINAL HEALTHCardinal Health 200, LLCPKA2024-06-15
10197106655030CARDINAL HEALTHCardinal Health 200, LLCPKA2024-05-16
50197106655038CARDINAL HEALTHCardinal Health 200, LLCPKA2024-05-16
10197106626474CARDINAL HEALTHCardinal Health 200, LLCPKA2024-04-26
50197106626472CARDINAL HEALTHCardinal Health 200, LLCPKA2024-04-26
10197106524589CARDINAL HEALTHCardinal Health 200, LLCPKA2024-02-29
50197106524587CARDINAL HEALTHCardinal Health 200, LLCPKA2024-02-29
10197106572887CARDINAL HEALTHCardinal Health 200, LLCPKA2024-02-12
50197106572885CARDINAL HEALTHCardinal Health 200, LLCPKA2024-02-12
10197106481875CARDINAL HEALTHCardinal Health 200, LLCPKA2023-12-27
50197106481873CARDINAL HEALTHCardinal Health 200, LLCPKA2023-12-27
10197106293171CARDINAL HEALTHCardinal Health 200, LLCPKA2023-06-23
50197106293179CARDINAL HEALTHCardinal Health 200, LLCPKA2023-06-23
10197106295083CARDINAL HEALTHCardinal Health 200, LLCPKA2023-06-14
50197106295081CARDINAL HEALTHCardinal Health 200, LLCPKA2023-06-14
10197106210567CARDINAL HEALTHCardinal Health 200, LLCPKA2023-05-04
50197106210565CARDINAL HEALTHCardinal Health 200, LLCPKA2023-05-04
10197106191491CARDINAL HEALTHCardinal Health 200, LLCPKA2023-03-29
50197106191499CARDINAL HEALTHCardinal Health 200, LLCPKA2023-03-29