Oral-Eze 96500

GUDID 00859952006086

ORAL EZE KIT W/SPECIMEN BAG 25/CS

CAPITOL VIAL, INC.

Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD
Primary Device ID00859952006086
NIH Device Record Key69491eee-2e63-415a-9d03-55474720c393
Commercial Distribution StatusIn Commercial Distribution
Brand NameOral-Eze
Version Model Number96500
Catalog Number96500
Company DUNS151639481
Company NameCAPITOL VIAL, INC.
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-232-3342
Emailxx@xx.xx
Phone1-800-232-3342
Emailxx@xx.xx
Phone1-800-232-3342
Emailxx@xx.xx
Phone1-800-232-3342
Emailxx@xx.xx
Phone1-800-232-3342
Emailxx@xx.xx
Phone1-800-232-3342
Emailxx@xx.xx
Phone1-800-232-3342
Emailxx@xx.xx
Phone1-800-232-3342
Emailxx@xx.xx
Phone1-800-232-3342
Emailxx@xx.xx
Phone1-800-232-3342
Emailxx@xx.xx
Phone1-800-232-3342
Emailxx@xx.xx
Phone1-800-232-3342
Emailxx@xx.xx
Phone1-800-232-3342
Emailxx@xx.xx
Phone1-800-232-3342
Emailxx@xx.xx
Phone1-800-232-3342
Emailxx@xx.xx
Phone1-800-232-3342
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from prolonged exposure to direct sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from prolonged exposure to direct sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from prolonged exposure to direct sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from prolonged exposure to direct sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from prolonged exposure to direct sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from prolonged exposure to direct sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from prolonged exposure to direct sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from prolonged exposure to direct sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from prolonged exposure to direct sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from prolonged exposure to direct sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from prolonged exposure to direct sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from prolonged exposure to direct sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from prolonged exposure to direct sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from prolonged exposure to direct sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from prolonged exposure to direct sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100859952006048 [Unit of Use]
GS100859952006086 [Primary]

FDA Product Code

PJDOral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-04-27

On-Brand Devices [Oral-Eze]

00859952006109ORAL EZE KIT W/SPECIMEN BAG 5/CS
00859952006093ORAL EZE KIT W/BAG/FEDEX LABEL 5/CS
00859952006086ORAL EZE KIT W/SPECIMEN BAG 25/CS
00859952006079ORAL EZE  KIT W/SPECIMEN BAG 100/CS
00859952006062ORAL EZE KIT W/BAG/FEDEX LABEL 100/CS
00859952006055ORAL EZE KIT W/BAG/FEDEX LABEL 25/CS
00859952006031ORAL-EZE MCCOYS BAG KIT
00859952006024ORAL-EZE PUBLIX BAG KIT
00859952006017ORAL-EZE ORAL COLL SYS
00859952006000ORAL-EZE ORAL COLL SYS
30859952006261ORAL-EZE ORAL COLL SYS
10859952006045ORAL EZE KIT - PACKAGED 25 KITS PER BAG

Trademark Results [Oral-Eze]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ORAL-EZE
ORAL-EZE
75420269 2393896 Live/Registered
LABONE, INC.
1998-01-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.