FDA UDI
In Commercial Distribution
🇺🇸 United States
Oral-Eze
DI: 10859952006236
·
Model: SA96100
·
CAPITOL VIAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
21
Pkg Device Count
1
Basic Information
- Brand Name
- Oral-Eze
- Primary DI
- 10859952006236
- Version / Model
- SA96100
- Company Name
- CAPITOL VIAL, INC.
- Labeler DUNS
- 151639481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-31
- Public Version
- 4
- Public Version Date
- 2023-08-23
- Public Version Status
- Update
- Public Device Record Key
- d629080a-f4c6-4d93-8955-191a7338c549
Device Description
ORAL-EZE ORAL COLL SYS
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PJD | Oral fluid drugs of abuse and alcohol test specimen collection device | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38868 | Drug-testing specimen collection kit IVD | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30859952006261 | GS1 | PACKAGE | 25 | In Commercial Distribution | |
| Primary | 10859952006236 | GS1 | ||||
| Package | 30859952006384 | GS1 | Case | 5 | In Commercial Distribution | |
| Package | 30859952006308 | GS1 | Case | 25 | In Commercial Distribution | |
| Package | 30859952006322 | GS1 | Case | 5 | In Commercial Distribution | |
| Package | 30859952006230 | GS1 | Case | 100 | In Commercial Distribution | |
| Package | 30859952006315 | GS1 | Case | 100 | In Commercial Distribution | |
| Package | 30859952006247 | GS1 | Case | 25 | In Commercial Distribution | |
| Package | 30859952006353 | GS1 | Case | 5 | In Commercial Distribution | |
| Package | 30859952006292 | GS1 | Case | 100 | In Commercial Distribution | |
| Package | 30859952006285 | GS1 | Case | 25 | In Commercial Distribution | |
| Package | 30859952006391 | GS1 | Case | 25 | In Commercial Distribution | |
| Package | 30859952006278 | GS1 | Case | 250 | In Commercial Distribution | |
| Package | 30859952006377 | GS1 | Case | 100 | In Commercial Distribution | |
| Package | 30859952006339 | GS1 | Case | 5 | In Commercial Distribution | |
| Package | 30859952006346 | GS1 | Case | 100 | In Commercial Distribution | |
| Package | 30859952006360 | GS1 | Case | 25 | In Commercial Distribution | |
| Package | 30859952006254 | GS1 | Case | 300 | In Commercial Distribution | |
| Package | 70859952006238 | GS1 | Case | 25 | In Commercial Distribution | |
| Package | 90859952006232 | GS1 | Case | 100 | In Commercial Distribution | |
| Package | 50859952006234 | GS1 | Case | 5 | In Commercial Distribution |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from prolonged exposure to direct sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius