FDA UDI
In Commercial Distribution
🇺🇸 United States
Rite Aid
DI: 00011822820356
·
Model: SI30
·
RITE AID CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Rite Aid
- Primary DI
- 00011822820356
- Version / Model
- SI30
- Company Name
- RITE AID CORPORATION
- Labeler DUNS
- 014578892
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-31
- Public Version
- 1
- Public Version Date
- 2022-06-08
- Public Version Status
- New
- Public Device Record Key
- fcb5f303-4a64-4450-861b-7025ae9dec96
Device Description
SI30, Article No. 603.84, Personal Steam Inhaler
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KFZ | Humidifier, Non-Direct Patient Interface (Home-Use) | Anesthesiology | 868.5460 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63562 | Home-use facial steamer | An electrically-powered device designed to create steam for facial skin cleansing, typically by providing a cone-shaped applicator for channelling the steam to the face. It may also be used for clearing the nasal passages by inhalation of the steam. It is normally available [non-prescription] over-the-counter (OTC) for use in the home. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10011822820353 | GS1 | Case Package | 6 | In Commercial Distribution | |
| Primary | 00011822820356 | GS1 |
Customer Contacts
- Phone
- 8005360366
- [email protected]