FDA.report

CARDINAL HEALTH

Primary DI
50195594068385
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
03-3766C
Catalog number
03-3766C
Device description
HEMODIALYSIS ON OFF PACK
Published
2021-11-24
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
50195594068385PackageGS124In Commercial Distribution
10195594068387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019559406838550195594068385
1019559406838710195594068387

GMDN Terms

TermDefinition
Urological surgical procedure kit, non-medicated, single-useA collection of various sterile urological surgical instruments and the necessary materials intended to be used to perform a urological surgical procedure. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of urological surgical procedure, but are often supplied together to perform a specific type of urological procedure; it does not contain any 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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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50198956094725CARDINAL HEALTHCardinal Health 200, LLCFKG2025-06-10
50197106986491CARDINAL HEALTHCardinal Health 200, LLCFKG2025-03-21
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00653160375176MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-05-28
00653160373585MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-04-25
20809160422684Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.FKG2024-03-28
00653160372403MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-03-15
50197106349869CARDINAL HEALTHCardinal Health 200, LLCFKG2023-09-29
50197106347186CARDINAL HEALTHCardinal Health 200, LLCFKG2023-07-25
00653160361001MEDLINEMEDLINE INDUSTRIES, INC.FKG2023-06-16
50197106092451CARDINAL HEALTHCardinal Health 200, LLCFKG2023-06-09
00653160359633MEDLINEMEDLINE INDUSTRIES, INC.FKG2023-04-28
50197106230990CARDINAL HEALTHCardinal Health 200, LLCFKG2023-04-25
50197106200290CARDINAL HEALTHCardinal Health 200, LLCFKG2023-04-18
50197106212651CARDINAL HEALTHCardinal Health 200, LLCFKG2023-04-18
00653160359541CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFKG2023-04-14
50197106198429CARDINAL HEALTHCardinal Health 200, LLCFKG2023-03-30
50197106174294CARDINAL HEALTHCardinal Health 200, LLCFKG2023-03-29
50197106156009CARDINAL HEALTHCardinal Health 200, LLCFKG2023-03-03
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00653160356076CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFKG2022-11-15
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50195594756831CARDINAL HEALTHCardinal Health 200, LLCFKG2022-07-29
50195594758521CARDINAL HEALTHCardinal Health 200, LLCFKG2022-07-29
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