FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594162687
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
OTC
false
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

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
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
10195594162689CARDINAL HEALTHCardinal Health 200, LLCPSG2021-07-09
10195594959470CARDINAL HEALTHCardinal Health 200, LLCPSG2021-04-05
50195594959478CARDINAL HEALTHCardinal Health 200, LLCPSG2021-04-05