FDA.report

Dover

Primary DI
50192253051603
Brand
Dover
Company
Cardinal Health 200, LLC
Model
4090SA
Catalog number
4090SA
Device description
Dover Midstream Specimen Catch Kit, Castile Soap Towelettes, Protected Ring 4 oz (118 mL)
Published
2024-08-20
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
50192253051603PackageGS1100In Commercial Distribution
10192253051605PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019225305160350192253051603
1019225305160510192253051605

GMDN Terms

TermDefinition
Midstream urine specimen container IVDA covered plastic receptacle with no additives intended to be used for the collection, and preservation and/or transport, of a midstream urine specimen for analysis and/or other investigation. The midstream is collected after an initial pre-measured volume of first-voided urine is diverted to a separate reservoir for discarding. Additional items may be included (e.g., towelettes). This is a single-use device.

Device Sizes

TypeValueUnit
Total Volume4Fluid Ounce

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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