FDA.reportPublic FDA data

Blood - Urine Specimen Convenience Kit

Primary DI
10859952006038
Brand
Blood - Urine Specimen Convenience Kit
Company
CAPITOL VIAL, INC.
Model
SA93508
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
30859952006032PackageGS148Not in Commercial Distribution
10859952006038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085995200603230859952006032
1085995200603810859952006038

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
10859952006052Blood Specimen Convenience KitSA947212018-08-31
10859952006069Blood Specimen Convenience KitSA952012018-08-31
10859952006076Blood Specimen Convenience KitSA952042018-08-31
10859952006090Blood - Urine Specimen KitSA946332018-08-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08887629000008BUHNSP TECH PTE LTDJKA2026-05-29
08887629000053BUCANSP TECH PTE LTDJKA2026-05-29
08887629000060BTANSP TECH PTE LTDJKA2026-05-29
08586015044786CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044793CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044809CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044816CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044823CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044878CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
10197344019649MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-04-23
10197344039715MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-04-17
10197344039708MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-04-16
10197344132911MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-01-23
10197344132928MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-01-23
10850074089060SurgycoSurgyco LLCJKA2025-12-23
10850074089077SurgycoSurgyco LLCJKA2025-12-23
10850074089084SurgycoSurgyco LLCJKA2025-12-23
10850074089091SurgycoSurgyco LLCJKA2025-12-23
10850074089107SurgycoSurgyco LLCJKA2025-12-23
10850074089114SurgycoSurgyco LLCJKA2025-12-23
10612479275635McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
10612479275666McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
10612479275697McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
10612479275727McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
10612479275758McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
10612479275789McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14