FDA.reportPublic FDA data

Blood - Urine Speciment Convenience Kit

Primary DI
00859952006116
Brand
Blood - Urine Speciment Convenience Kit
Company
CAPITOL VIAL, INC.
Model
SA93010
Catalog number
SA93010
Device description
Blood - Urine Specimen Convenience Kit
Published
2017-08-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
10859952006113PackageGS148In Commercial Distribution
00859952006116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085995200611310859952006113
00859952006116008599520061168599520061160859952006116

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, potassium oxalate/sodium fluorideA sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, the anticoagulant potassium oxalate and the antiglycolytic agent sodium fluoride. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., blood glucose or lactate determinations). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-772-8871xx@xx.xx

Regulatory Flags#

DUNS number
151639481
Device count
1
Kit
true
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
10859952006090Blood - Urine Specimen KitSA946332018-08-31
10859952006236Oral-EzeSA961002018-08-31
10859952006403Blood Specimen Convenience KitSA940812018-10-29
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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