FDA UDI
In Commercial Distribution
🇺🇸 United States
PREMIER
DI: 00840986010095
·
Model: 93965HZ
·
PHARMACY VALUE ALLIANCE, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- PREMIER
- Primary DI
- 00840986010095
- Version / Model
- 93965HZ
- Catalog Number
- 93965HZ
- Company Name
- PHARMACY VALUE ALLIANCE, LLC
- Labeler DUNS
- 089138159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 7e96d958-2eee-443d-8328-832e74407122
Device Description
PREMIER VALUE MPS 360ML
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LPN | Accessories, soft lens products | Ophthalmic | 886.5928 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45870 | Multi-purpose soft contact lens solution | A sterile aqueous formulation containing appropriate agents typically for cleaning, rinsing, protein removal, disinfecting, storing, and possibly wetting reusable soft contact lenses. The solution may be specific to a type of procedure (e.g., manual, heated, or ultrasonic). After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840986010095 | GS1 | ||||
| Package | 10840986010092 | GS1 | Box | 3 | In Commercial Distribution | |
| Package | 20840986010099 | GS1 | Case | 8 | In Commercial Distribution |