FDA.report

CARDINAL HEALTH

Primary DI
50195594523853
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN54PDE10
Catalog number
SAN54PDE10
Device description
PORT DIALYSIS PACK
Published
2022-02-03
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

Related Records

Product Codes

CodeName
FKGTRAY, START/STOP (INCLUDING CONTENTS), DIALYSIS

Product Code Classifications

CodeDeviceSpecialtyClass
FKGTray, Start/Stop (Including Contents), DialysisGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50195594523853PackageGS14In Commercial Distribution
10195594523855PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019559452385350195594523853
1019559452385510195594523855

GMDN Terms

TermDefinition
Nephroscopic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical and endoscopic instruments, dressings and the necessary materials used to perform a nephroscopic surgical procedure. It does not contain pharmaceuticals. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

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

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50198956314687CARDINAL HEALTHSMAHDGVAAGSMAHDGVAAG2026-03-24
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50198956328851CARDINAL HEALTHSANCGRPILCSANCGRPILC2026-03-24
50198956334760CARDINAL HEALTHSBACGHERIFSBACGHERIF2026-03-24
50198956335569CARDINAL HEALTHSNE19NSKHRSNE19NSKHR2026-03-24

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Primary DIBrandCompanyProduct codePublished
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00653160373585MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-04-25
20809160422684Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.FKG2024-03-28
00653160372403MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-03-15
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50197106347186CARDINAL HEALTHCardinal Health 200, LLCFKG2023-07-25
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50197106212651CARDINAL HEALTHCardinal Health 200, LLCFKG2023-04-18
00653160359541CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFKG2023-04-14
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00653160356076CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFKG2022-11-15
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