FDA.report

CARDINAL HEALTH

Primary DI
10885380177095
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
C13904ITD
Catalog number
C13904ITD
Device description
Urine Collection Cup 120ML
Published
2020-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FMHCONTAINER, SPECIMEN, STERILE

Product Code Classifications

CodeDeviceSpecialtyClass
FMHContainer, Specimen, SterilePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50885380177093PrimaryGS10
10885380177095Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5088538017709350885380177093
1088538017709510885380177095

GMDN Terms

TermDefinition
General specimen receptacle transport containerA non-sterile, portable device designed for the transportation of one or multiple clinical specimen receptacles (e.g., glass vials, bottles, tubes, slides, swabs) from the point of collection to the laboratory or between medical institutions. It is typically designed to be liquid-tight with a shock-absorbing foam liner to protect the contents from adverse conditions that could cause breakage and to absorb any escaped fluid. It is available in a variety of sizes, shapes, and materials. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
300
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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