Oral-Eze
GUDID 30859952006261
ORAL-EZE ORAL COLL SYS
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 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 ID | 30859952006261 |
| NIH Device Record Key | d629080a-f4c6-4d93-8955-191a7338c549 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Oral-Eze |
| Version Model Number | SA96100 |
| Company DUNS | 151639481 |
| Company Name | CAPITOL VIAL, INC. |
| Device Count | 1 |
| 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 | false |
| 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 | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Protect from prolonged exposure to direct sunlight |
| Storage 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 |
| Storage 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 |
| Storage 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 |
| Storage 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 |
| Storage 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 |
| Storage 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 |
| Storage 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 |
| Storage 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 |
| Storage 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 |
| Storage 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 |
| Storage 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 |
| Storage 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 |
| Storage 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 |
| Storage 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 |
| Storage 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 |
| Storage 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 |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10859952006236 [Primary] |
| GS1 | 30859952006230 [Package] Contains: 10859952006236 Package: Case [100 Units] In Commercial Distribution |
| GS1 | 30859952006247 [Package] Contains: 10859952006236 Package: Case [25 Units] In Commercial Distribution |
| GS1 | 30859952006254 [Package] Contains: 10859952006236 Package: Case [300 Units] In Commercial Distribution |
| GS1 | 30859952006261 [Package] Contains: 10859952006236 Package: PACKAGE [25 Units] In Commercial Distribution |
| GS1 | 30859952006278 [Package] Package: Case [250 Units] In Commercial Distribution |
| GS1 | 30859952006285 [Package] Contains: 10859952006236 Package: Case [25 Units] In Commercial Distribution |
| GS1 | 30859952006292 [Package] Contains: 10859952006236 Package: Case [100 Units] In Commercial Distribution |
| GS1 | 30859952006308 [Package] Contains: 10859952006236 Package: Case [25 Units] In Commercial Distribution |
| GS1 | 30859952006315 [Package] Contains: 10859952006236 Package: Case [100 Units] In Commercial Distribution |
| GS1 | 30859952006322 [Package] Contains: 10859952006236 Package: Case [5 Units] In Commercial Distribution |
| GS1 | 30859952006339 [Package] Contains: 10859952006236 Package: Case [5 Units] In Commercial Distribution |
| GS1 | 30859952006346 [Package] Contains: 10859952006236 Package: Case [100 Units] In Commercial Distribution |
| GS1 | 30859952006353 [Package] Contains: 10859952006236 Package: Case [5 Units] In Commercial Distribution |
| GS1 | 30859952006360 [Package] Contains: 10859952006236 Package: Case [25 Units] In Commercial Distribution |
| GS1 | 30859952006377 [Package] Contains: 10859952006236 Package: Case [100 Units] In Commercial Distribution |
| GS1 | 30859952006384 [Package] Contains: 10859952006236 Package: Case [5 Units] In Commercial Distribution |
| GS1 | 30859952006391 [Package] Contains: 10859952006236 Package: Case [25 Units] In Commercial Distribution |
| GS1 | 50859952006234 [Package] Contains: 10859952006236 Package: Case [5 Units] In Commercial Distribution |
| GS1 | 70859952006238 [Package] Contains: 10859952006236 Package: Case [25 Units] In Commercial Distribution |
| GS1 | 90859952006232 [Package] Contains: 10859952006236 Package: Case [100 Units] In Commercial Distribution |
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 | 3 |
| Public Version Date | 2021-07-22 |
| Device Publish Date | 2018-08-31 |
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 |
Trademark Results [Oral-Eze]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 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.