FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439561935
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBAEWATMQA
Catalog number
SBAEWATMQA
Device description
CATHERIZATION PACK
Published
2019-08-27
Public version status
Update
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
PPCMale external catheterization kit (excludes HIV testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPCMale External Catheterization Kit (Excludes Hiv Testing)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50888439561935PackageGS110In Commercial Distribution
10888439561937PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843956193550888439561935
1088843956193710888439561937

GMDN Terms#

Term, Definition table
TermDefinition
Urological surgical procedure kit, non-medicated, single-useA collection of various urological surgical instruments and the necessary materials intended to be used during a urological surgical/endoscopic procedure; it is not a dedicated bladder irrigation set. 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 urological surgical procedure, but are often supplied together to perform a specific type of urological procedure; it does not contain any pharmaceuticals. This is a single-use device.

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
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
10801741183628SureStep Male External Catheter SystemC. R. Bard, Inc.PPC2020-09-22
10801741183635SureStep Male External Catheter SystemC. R. Bard, Inc.PPC2020-09-22
10801741183642SureStep Male External Catheter System Orange Replacement KitC. R. Bard, Inc.PPC2020-09-22
10801741183659SureStep Male External Catheter System Green Replacement KitC. R. Bard, Inc.PPC2020-09-22
10801741183666SureStep Male External Catheter System Blue Replacement KitC. R. Bard, Inc.PPC2020-09-22
10801741183673SureStep Male External Catheter System Violet Replacement KitC. R. Bard, Inc.PPC2020-09-22
10888439561937CARDINAL HEALTHCardinal Health 200, LLCPPC2019-08-27
10888439548457CARDINAL HEALTHCardinal Health 200, LLCPPC2019-08-06
50888439548455CARDINAL HEALTHCardinal Health 200, LLCPPC2019-08-06
20884521001005DoverCardinal Health, Inc.PPC2016-09-24
20884521004433DoverCardinal Health, Inc.PPC2016-09-24
20884521005324DoverCardinal Health, Inc.PPC2016-09-24
20884521008424DoverCardinal Health, Inc.PPC2016-09-24
20884521008479DoverCardinal Health, Inc.PPC2016-09-24
20884521008486DoverCardinal Health, Inc.PPC2016-09-24
20884521008493DoverCardinal Health, Inc.PPC2016-09-24
20884521008516DoverCardinal Health, Inc.PPC2016-09-24
20884521008561DoverCardinal Health, Inc.PPC2016-09-24
20884521008592DoverCardinal Health, Inc.PPC2016-09-24
20884521008615DoverCardinal Health, Inc.PPC2016-09-24
20884521009377DoverCardinal Health, Inc.PPC2016-09-24
20884521009384DoverCardinal Health, Inc.PPC2016-09-24
20884521009421DoverCardinal Health, Inc.PPC2016-09-24
20884521009445DoverCardinal Health, Inc.PPC2016-09-24
20884521009476DoverCardinal Health, Inc.PPC2016-09-24
30884521009480DoverCardinal Health, Inc.PPC2016-09-24
20884521009490DoverCardinal Health, Inc.PPC2016-09-24
20884521009513DoverCardinal Health, Inc.PPC2016-09-24
20884521009575DoverCardinal Health, Inc.PPC2016-09-24
30884521009503DoverCardinal Health, Inc.PPC2016-09-24