Oral-Eze

Primary DI
30859952006261
Brand
Oral-Eze
Company
CAPITOL VIAL, INC.
Model
SA96100
Device description
ORAL-EZE ORAL COLL SYS
Published
2018-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
PJDOral fluid drugs of abuse and alcohol test specimen collection device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PJDOral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection DeviceClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30859952006230PackageGS1100In Commercial Distribution
30859952006247PackageGS125In Commercial Distribution
30859952006254PackageGS1300In Commercial Distribution
30859952006261PackageGS125In Commercial Distribution
30859952006278PackageGS1250In Commercial Distribution
30859952006285PackageGS125In Commercial Distribution
30859952006292PackageGS1100In Commercial Distribution
30859952006308PackageGS125In Commercial Distribution
30859952006315PackageGS1100In Commercial Distribution
30859952006322PackageGS15In Commercial Distribution
30859952006339PackageGS15In Commercial Distribution
30859952006346PackageGS1100In Commercial Distribution
30859952006353PackageGS15In Commercial Distribution
30859952006360PackageGS125In Commercial Distribution
30859952006377PackageGS1100In Commercial Distribution
30859952006384PackageGS15In Commercial Distribution
30859952006391PackageGS125In Commercial Distribution
50859952006234PackageGS15In Commercial Distribution
70859952006238PackageGS125In Commercial Distribution
90859952006232PackageGS1100In Commercial Distribution
10859952006236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085995200623030859952006230
3085995200624730859952006247
3085995200625430859952006254
3085995200626130859952006261
3085995200627830859952006278
3085995200628530859952006285
3085995200629230859952006292
3085995200630830859952006308
3085995200631530859952006315
3085995200632230859952006322
3085995200633930859952006339
3085995200634630859952006346
3085995200635330859952006353
3085995200636030859952006360
3085995200637730859952006377
3085995200638430859952006384
3085995200639130859952006391
5085995200623450859952006234
7085995200623870859952006238
9085995200623290859952006232
1085995200623610859952006236

GMDN Terms#

Term, Definition table
TermDefinition
Drug-testing specimen collection kit IVDA covered receptacle and other associated materials/tools, available for use in the home and clinical settings, intended to be used for the collection, and preservation and/or transport, of a clinical specimen that may include hair, urine, sweat, or saliva suitable for drug testing and/or other in vitro diagnostic investigation. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from prolonged exposure to direct sunlight
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
151639481
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840937103142Immunalysis IMMUNALYSIS CORPORATIONPJD2023-03-29
00840937112052QuantisalIMMUNALYSIS CORPORATIONPJD2020-10-06
00840937112069QuantisalIMMUNALYSIS CORPORATIONPJD2020-10-06
00840937112144ImmunalysisIMMUNALYSIS CORPPJD2020-08-31
00840937112151QuantisalIMMUNALYSIS CORPORATIONPJD2020-08-31
00840937112168QuantisalIMMUNALYSIS CORPORATIONPJD2020-08-31
00608337000115OraSure Oral Fluid Collection DeviceOrasure Technologies, Inc.PJD2019-02-15
20608337000119OraSure Oral Fluid Collection DeviceOrasure Technologies, Inc.PJD2019-02-15
10859952006236Oral-EzeCAPITOL VIAL, INC.PJD2018-08-31
00840937110812ImmunalysisIMMUNALYSIS CORPPJD2018-04-20
00840937110829ImmunalysisIMMUNALYSIS CORPPJD2018-04-20
10859952006045Oral-EzeCAPITOL VIAL, INC.PJD2018-01-12
00884883012639Oral-Eze Sample ExtractorMicrogenics CorporationPJD2017-12-20
00884883012646Oral-Eze Sample ExtractorMicrogenics CorporationPJD2017-12-20
00859952006093Oral-EzeCAPITOL VIAL, INC.PJD2017-07-25
00859952006109Oral-EzeCAPITOL VIAL, INC.PJD2017-07-25
00859952006055Oral-EzeCAPITOL VIAL, INC.PJD2017-04-27
00859952006062Oral-EzeCAPITOL VIAL, INC.PJD2017-04-27
00859952006079Oral-EzeCAPITOL VIAL, INC.PJD2017-04-27
00859952006086Oral-EzeCAPITOL VIAL, INC.PJD2017-04-27
00884883012585Oral-Eze Collection SystemMicrogenics CorporationPJD2016-09-12
00884883012653Oral-Eze Collection SystemMicrogenics CorporationPJD2016-09-12
00859952006000Oral-EzeCAPITOL VIAL, INC.PJD2016-09-10
00859952006017Oral-EzeCAPITOL VIAL, INC.PJD2016-09-10
00859952006024Oral-EzeCAPITOL VIAL, INC.PJD2016-09-10
00859952006031Oral-EzeCAPITOL VIAL, INC.PJD2016-09-10
00840937105078ImmunalysisIMMUNALYSIS CORPPJD2016-08-31