FDA UDI
In Commercial Distribution
🇺🇸 United States
Molekule Air Mini
DI: 00818701020520
·
Model: MN1B-US
·
MOLEKULE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Molekule Air Mini
- Primary DI
- 00818701020520
- Version / Model
- MN1B-US
- Company Name
- MOLEKULE, INC.
- Labeler DUNS
- 080508772
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-25
- Public Version
- 4
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- 50596adc-1eac-4308-a1e3-b93446c2ef3c
Device Description
The Molekule Air Mini air purifier is a device intended for medical purposes that is used to destroy bacteria and viruses in the air by exposure to ultraviolet radiation
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
- Yes
- 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 |
|---|---|---|---|---|
| FRA | Purifier, Air, Ultraviolet, Medical | General Hospital | 880.6500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35150 | Ultraviolet ambient disinfection light | An electrically-powered light source designed to destroy bacteria and viruses in the air and/or on surfaces by emission of ultraviolet radiation into the surrounding environment. It is a mounted, or self-standing device, consisting of a tubular bulb or a unit containing the light source, and may include automatic motion sensors or timers, but does not include a user control unit or radiometers. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00818701020520 | GS1 |
Customer Contacts
- Phone
- 855-999-9069
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202339 | 000 |