FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594277345
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT69CBKR1
Catalog number
SOT69CBKR1
Device description
CBI PACK
Published
2021-08-20
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
PPABladder irrigation kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPABladder Irrigation KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594277343PackageGS14In Commercial Distribution
10195594277345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559427734350195594277343
1019559427734510195594277345

GMDN Terms#

Term, Definition table
TermDefinition
Urological surgical procedure kit, medicated, single-useA collection of various sterile urological surgical instruments, dressings, pharmaceuticals, and the necessary materials intended to be used to perform a urological surgical procedure; is not dedicated to a specific type of urological surgical procedure. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 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
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197106911266CARDINAL HEALTHSBA60POLHCSBA60POLHC2026-06-08
10197106983577CARDINAL HEALTHSEN69ERMVDSEN69ERMVD2026-06-08
10198956182264CARDINAL HEALTHSCV43OOTGKSCV43OOTGK2026-06-08
10198956218611CARDINAL HEALTHSOP55AOKFJSOP55AOKFJ2026-06-08
10198956227552CARDINAL HEALTHSEY33EPCAFSEY33EPCAF2026-06-08
10198956279391CARDINAL HEALTH01-0111A01-0111A2026-06-08
10198956312920CARDINAL HEALTHSMA57CESARSMA57CESAR2026-06-08
10198956332096CARDINAL HEALTHSOP32THGMLSOP32THGML2026-06-08
10198956336865CARDINAL HEALTHPN73CRKPBPN73CRKPB2026-06-08
10198956343139CARDINAL HEALTHSOP45HAOCCSOP45HAOCC2026-06-08
10198956359024CARDINAL HEALTHSBA24UPJRGSBA24UPJRG2026-06-08
10198956362932CARDINAL HEALTHSEN48TASABSEN48TASAB2026-06-08
10198956364349CARDINAL HEALTHSBACGRPGRASBACGRPGRA2026-06-08
10198956364783CARDINAL HEALTHSNE38LMCIBSNE38LMCIB2026-06-08
10198956373372CARDINAL HEALTHSOP31EXHNGSOP31EXHNG2026-06-08
10198956373976CARDINAL HEALTHSOP38SHUSHSOP38SHUSH2026-06-08
10198956374119CARDINAL HEALTHSBA56LPSTCSBA56LPSTC2026-06-08
10198956386150CARDINAL HEALTHSEN69SPREBSEN69SPREB2026-06-08
10198956387171CARDINAL HEALTHSBA41PLRSESBA41PLRSE2026-06-08
10198956390430CARDINAL HEALTHSEN37TSPSDSEN37TSPSD2026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160429372Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PPA2024-07-09
20809160429379Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PPA2024-07-09
10809160372982MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PPA2022-06-10
20809160372989MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PPA2022-06-10
10195594345419CARDINAL HEALTHCardinal Health 200, LLCPPA2021-10-12
50195594345417CARDINAL HEALTHCardinal Health 200, LLCPPA2021-10-12
50195594277343CARDINAL HEALTHCardinal Health 200, LLCPPA2021-08-20
00616784426624Irrigation Tray with 60cc Bulb SyringesDynarex CorporationPPA2021-06-21
00616784426822Irrigation Tray with 60cc Piston SyringeDynarex CorporationPPA2021-06-21
10195594963880CARDINAL HEALTHCardinal Health 200, LLCPPA2021-05-03
50195594963888CARDINAL HEALTHCardinal Health 200, LLCPPA2021-05-03
10194717102281Regard™ROI CPS, LLCPPA2020-01-03
20194717102288Regard™ROI CPS, LLCPPA2020-01-03
10194717102298Regard™ROI CPS, LLCPPA2019-11-21
20194717102295Regard™ROI CPS, LLCPPA2019-11-21
10194717102304Regard™ROI CPS, LLCPPA2019-10-28
20194717102301Regard™ROI CPS, LLCPPA2019-10-28
10809160201503MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PPA2018-07-27
20809160201500MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PPA2018-07-27
10326053113045Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.PPA2017-04-20
10326053113052Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.PPA2017-04-20
20326053113042Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.PPA2017-04-20
20326053113059Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.PPA2017-04-20
10326053112970Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.PPA2017-02-16
20326053112977Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.PPA2017-02-16