FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594162689
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBADKPPRPC
Catalog number
SBADKPPRPC
Device description
PEG PACK
Published
2021-07-09
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
PSGPercutaneous endoscopic gastrostomy kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PSGPercutaneous Endoscopic Gastrostomy KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594162687PackageGS13In Commercial Distribution
10195594162689PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559416268750195594162687
1019559416268910195594162689

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
No 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
10197106971246CARDINAL HEALTHCardinal Health 200, LLCPSG2025-02-28
50197106971244CARDINAL HEALTHCardinal Health 200, LLCPSG2025-02-28
10197106068038CARDINAL HEALTHCardinal Health 200, LLCPSG2023-11-13
50197106068036CARDINAL HEALTHCardinal Health 200, LLCPSG2023-11-13
10197106266434CARDINAL HEALTHCardinal Health 200, LLCPSG2023-05-08
50197106266432CARDINAL HEALTHCardinal Health 200, LLCPSG2023-05-08
10197106106075CARDINAL HEALTHCardinal Health 200, LLCPSG2023-01-20
50195594162687CARDINAL HEALTHCardinal Health 200, LLCPSG2021-07-09
10195594959470CARDINAL HEALTHCardinal Health 200, LLCPSG2021-04-05
50195594959478CARDINAL HEALTHCardinal Health 200, LLCPSG2021-04-05