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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

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