FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106068038
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBADKPPRPE
Catalog number
SBADKPPRPE
Device description
PEG PACK
Published
2023-11-13
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
50197106068036PackageGS13In Commercial Distribution
10197106068038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710606803650197106068036
1019710606803810197106068038

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
10885380184895CARDINAL HEALTH82021820212024-07-25
10885380184901CARDINAL HEALTH82022820222024-07-25
10885380184918CARDINAL HEALTH82023820232024-07-25
10885380184925CARDINAL HEALTH82024820242024-07-25
50885380004818CONVERTORS9423N9423N2016-06-21
50885380009837CONVERTORS29455NA29455NA2016-06-21
50885380016972CONVERTORS29557N29557N2016-06-21
50885380020016CONVERTORS9450N9450N2016-06-21
50885380027916CONVERTORS9441N9441N2016-06-21
50885380030619CONVERTORS29444N29444N2016-06-21
50885380034068CONVERTORS29527N29527N2016-06-21
50885380034402CONVERTORS29559N29559N2016-06-21
50885380036116CONVERTORS9449N9449N2016-06-21
50885380053755CONVERTORS29421NB29421NB2016-06-21
50885380053779CONVERTORS9438NB9438NB2016-06-21
50885380053854CONVERTORS29465NB29465NB2016-06-21
50885380053878CONVERTORS29467NB29467NB2016-06-21
50885380053892CONVERTORS29522NB29522NB2016-06-21
50885380053922CONVERTORS9430NB9430NB2016-06-21
50885380053939CONVERTORS9458NB9458NB2016-06-21

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
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
50195594162687CARDINAL HEALTHCardinal Health 200, LLCPSG2021-07-09
10195594959470CARDINAL HEALTHCardinal Health 200, LLCPSG2021-04-05
50195594959478CARDINAL HEALTHCardinal Health 200, LLCPSG2021-04-05