FDA UDI
In Commercial Distribution
🇺🇸 United States
EQUALINE
DI: 00041163472549
·
Model: 93805HZ
·
SUPERVALU INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- EQUALINE
- Primary DI
- 00041163472549
- Version / Model
- 93805HZ
- Catalog Number
- 93805HZ
- Company Name
- SUPERVALU INC.
- Labeler DUNS
- 006961411
- 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
- 3d6967e0-6149-4f08-bf0d-5ba5fe58e7e6
Device Description
EQUALINE CONTACT REWETTING DROPS, 15ML
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 |
|---|---|---|---|---|
| 48082 | Contact lens wetting solution | An aqueous formulation intended to wet contact lenses. The device is dispensed as droplets typically directly on the eyes while the patient wears the contact lenses; it is available in single- or multiple-dose containers. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10041163472546 | GS1 | Case | 4 | In Commercial Distribution | |
| Package | 20041163472543 | GS1 | Box | 6 | In Commercial Distribution | |
| Primary | 00041163472549 | GS1 |
Customer Contacts
- Phone
- +1(877)932-7948
- [email protected]