FDA.reportPublic FDA data

Blood - Urine Specimen Kit

Primary DI
10859952006090
Brand
Blood - Urine Specimen Kit
Company
CAPITOL VIAL, INC.
Model
SA94633
Device description
Convenience Kit
Published
2018-08-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JKATubes, vials, systems, serum separators, blood collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30859952006094PackageGS148Not in Commercial Distribution
10859952006090PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085995200609430859952006094
1085995200609010859952006090

GMDN Terms#

Term, Definition table
TermDefinition
Capillary blood collection system IVDAn assembly of devices intended to be used for the collection, preservation, and/or transportation of capillary blood for subsequent analysis and/or other investigation. It is a self-contained unit consisting of micro-needles and a container with a pre-measured amount of vacuum. The device is intended to be placed against the skin where the needles make shallow perforations, from which blood is drawn from the capillaries into the container via the vacuum. It may or may not contain a preservative or anticoagulant (e.g., lithium heparin). This is a single-use device.

Regulatory Flags#

DUNS number
151639481
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10859952006021Blood - Urine Specimen Convenience KitSA930102018-08-31
10859952006038Blood - Urine Specimen Convenience KitSA935082018-08-31
10859952006052Blood Specimen Convenience KitSA947212018-08-31
10859952006069Blood Specimen Convenience KitSA952012018-08-31
10859952006076Blood Specimen Convenience KitSA952042018-08-31
10859952006236Oral-EzeSA961002018-08-31
10859952006403Blood Specimen Convenience KitSA940812018-10-29
00859952006116Blood - Urine Speciment Convenience KitSA93010SA930102017-08-25
00859952006123Blood - Urine Specimen Convenience KitSA93508SA935082017-08-25
00859952006130Blood Specimen Conveneience KitSA94721SA947212017-08-25
00859952006147Blood Specimen Convenience KitSA95201SA952012017-08-25
00859952006154Blood Specimen Convenience KitSA95204SA952042017-08-25
30859952006025Blood - Urine Specimen Convenience KitSA930102018-08-31
30859952006032Blood - Urine Specimen Convenience KitSA935082018-08-31
50859952006050Blood Specimen Convenience KitSA947212018-08-31
30859952006063Blood Specimen Convenience KitSA952012018-08-31
30859952006070Blood Specimen Convenience KitSA952042018-08-31
30859952006094Blood - Urine Specimen KitSA946332018-08-31
30859952006407Blood Specimen Convenience KitSA940812018-10-29
10859952006045Oral-EzeSA962002018-01-12

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