FDA UDI
In Commercial Distribution
🇺🇸 United States
Oasis REST & RELIEF Eye Mask
DI: 00845819000076
·
Model: OM8000
·
OASIS MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Oasis REST & RELIEF Eye Mask
- Primary DI
- 00845819000076
- Version / Model
- OM8000
- Company Name
- OASIS MEDICAL, INC.
- Labeler DUNS
- 194121018
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-30
- Public Version
- 2
- Public Version Date
- 2026-01-12
- Public Version Status
- Update
- Public Device Record Key
- 9680bbec-f2b9-445f-a4a2-ada1fc6bfad4
Device Description
Oasis REST & RELIEF Eye Mask
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| IME | Pack, Hot Or Cold, Reusable | Physical Medicine | 890.5700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61023 | Eye hot/cold therapy mask, reusable | A non-powered device intended to be placed over closed eyes to apply heat/steam and/or cold to the eyes for the treatment of meibomian gland dysfunction (MGD), dry eye syndromes, blepharitis (inflammation of the eyelid), and other related ocular conditions. It is typically in the form of a mask-shaped fabric envelope which either: 1) contains a thermal-insulating substance intended to be heated in a microwave oven or cooled in a freezer prior to use; or 2) includes an envelope(s) filled with a material that produces an exothermic chemical reaction when activated. Some types have a non-pharmaceutical antimicrobial coating to reduce eye infection risk. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00845819000076 | GS1 |
Customer Contacts
- Phone
- 9093055400
- [email protected]