FDA UDI
In Commercial Distribution
🇺🇸 United States
REFRESH RELIEVA FOR CONTACTS
DI: 00300236632083
·
Model: 96632
·
Allergan, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- REFRESH RELIEVA FOR CONTACTS
- Primary DI
- 00300236632083
- Version / Model
- 96632
- Company Name
- Allergan, Inc.
- Labeler DUNS
- 144796497
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-27
- Public Version
- 2
- Public Version Date
- 2020-11-06
- Public Version Status
- Update
- Public Device Record Key
- 6203d410-1f05-4d30-a0bb-a24be6d7613e
Device Description
REFRESH RELIEVA FOR CONTACTS Lubricant Eye Drops
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
- Yes
- 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 |
|---|---|---|---|---|
| 44237 | Eye lubricant | A substance intended to provide supplemental lubrication/hydration to the natural eye to treat dry, tired, irritated, and/or strained eyes resulting from dry eye syndrome, ageing/hormone changes (menopause), or environmental factors (e.g., medications, pollution, computer use, air conditioning, allergy); some types may in addition be intended to wet contact lenses during wear. It may be a topical solution, spray, suspension, or gel applied to the eyes or eyelids, and may have special formulations (e.g., intensive, night use). It is intended for use in the home or healthcare facility (single dose or multidose). 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 | 00300236632083 | GS1 |
Customer Contacts
- Phone
- 18006781605
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190674 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit