FDA.reportPublic FDA data

Oral-Eze

Primary DI
00859952006109
Brand
Oral-Eze
Company
CAPITOL VIAL, INC.
Model
96505
Catalog number
96505
Device description
ORAL EZE KIT W/SPECIMEN BAG 5/CS
Published
2017-07-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
00859952006109PrimaryGS10
00859952006048Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859952006109008599520061098599520061090859952006109
00859952006048008599520060488599520060480859952006048

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

Contacts#

Phone, Email table
PhoneEmail
1-800-232-3342xx@xx.xx

Regulatory Flags#

DUNS number
151639481
Device count
5
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840937113912ImmunalysisIMMUNALYSIS CORPPJD2023-03-29
00840937113929ImmunalysisIMMUNALYSIS CORPPJD2023-03-29
00840937113936ImmunalysisIMMUNALYSIS CORPPJD2023-03-29
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
30859952006261Oral-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
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