Oral-Eze 96405

GUDID 00859952006093

ORAL EZE KIT W/BAG/FEDEX LABEL 5/CS

CAPITOL VIAL, INC.

Drug-testing specimen collection kit IVD

• Primary Device ID: 00859952006093
• NIH Device Record Key: d7c68e42-399a-40ea-86e7-03ba205a1730
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oral-Eze
• Version Model Number: 96405
• Catalog Number: 96405
• Company DUNS: 151639481
• Company Name: CAPITOL VIAL, INC.
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-232-3342
• Email: xx@xx.xx
• Phone: 1-800-232-3342
• Email: xx@xx.xx
• Phone: 1-800-232-3342
• Email: xx@xx.xx
• Phone: 1-800-232-3342
• Email: xx@xx.xx
• Phone: 1-800-232-3342
• Email: xx@xx.xx
• Phone: 1-800-232-3342
• Email: xx@xx.xx
• Phone: 1-800-232-3342
• Email: xx@xx.xx
• Phone: 1-800-232-3342
• Email: xx@xx.xx
• Phone: 1-800-232-3342
• Email: xx@xx.xx
• Phone: 1-800-232-3342
• Email: xx@xx.xx
• Phone: 1-800-232-3342
• Email: xx@xx.xx
• Phone: 1-800-232-3342
• Email: xx@xx.xx
• Phone: 1-800-232-3342
• Email: xx@xx.xx
• Phone: 1-800-232-3342
• Email: xx@xx.xx
• Phone: 1-800-232-3342
• Email: xx@xx.xx
• Phone: 1-800-232-3342
• Email: xx@xx.xx

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from prolonged exposure to direct sunlight
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from prolonged exposure to direct sunlight
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from prolonged exposure to direct sunlight
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from prolonged exposure to direct sunlight
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from prolonged exposure to direct sunlight
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from prolonged exposure to direct sunlight
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from prolonged exposure to direct sunlight
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from prolonged exposure to direct sunlight
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from prolonged exposure to direct sunlight
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from prolonged exposure to direct sunlight
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from prolonged exposure to direct sunlight
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from prolonged exposure to direct sunlight
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from prolonged exposure to direct sunlight
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from prolonged exposure to direct sunlight
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from prolonged exposure to direct sunlight
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859952006048 [Unit of Use]
GS1	00859952006093 [Primary]

FDA Product Code

• PJD: Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-07-25

On-Brand Devices [Oral-Eze]

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