FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106293171
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA3DDCMMP
Catalog number
SMA3DDCMMP
Device description
D AND C PACK
Published
2023-06-23
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
50197106293179PackageGS14In Commercial Distribution
10197106293171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710629317950197106293179
1019710629317110197106293171

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. 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
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

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
10197106690437CARDINAL HEALTHCardinal Health 200, LLCPKA2024-07-16
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
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