FDA UDI
In Commercial Distribution
🇺🇸 United States
Oral-Eze
DI: 10859952006045
·
Model: SA96200
·
CAPITOL VIAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
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Basic Information
- Brand Name
- Oral-Eze
- Primary DI
- 10859952006045
- Version / Model
- SA96200
- Company Name
- CAPITOL VIAL, INC.
- Labeler DUNS
- 151639481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2018-01-12
- Public Version
- 3
- Public Version Date
- 2021-07-22
- Public Version Status
- Update
- Public Device Record Key
- f909d48c-e4d2-49ad-a59f-a45f6af27d37
Device Description
ORAL EZE KIT - PACKAGED 25 KITS PER BAG
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|---|---|
| Primary | 10859952006045 | GS1 | ||||
| Unit of Use | 00859952006048 | GS1 |
Customer Contacts
- Phone
- 1-800-232-3342
- [email protected]
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