FDA UDI
In Commercial Distribution
🇺🇸 United States
O2asis Humidifier
DI: 00840106905461
·
Model: O2asis Humidifier Water Well
·
PERMA PURE LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- O2asis Humidifier
- Primary DI
- 00840106905461
- Version / Model
- O2asis Humidifier Water Well
- Company Name
- PERMA PURE LLC
- Labeler DUNS
- 063142533
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-07
- Public Version
- 1
- Public Version Date
- 2023-06-15
- Public Version Status
- New
- Public Device Record Key
- c9dbf2b6-0d0b-4a03-9b97-09c1ec341b69
Device Description
O2asis Humidifier Water Well
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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | Anesthesiology | 868.5450 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12050 | Heated respiratory humidifier | A mains electricity (AC-powered) device designed to heat and humidify air/oxygen inspired by a patient to help maintain the mucous membranes of the respiratory tract typically during periods of prolonged respiratory support/therapy (e.g., mechanical ventilation, BPAP/CPAP therapy). The heated/humidified gases are delivered to the patient's airway and lungs via the nose/mouth or a tracheostoma in association with a parent respiratory device (e.g., ventilator, BPAP/CPAP unit). The humidifier typically includes a heating element and provisions for attaching a humidification chamber and tubing set. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840106905461 | GS1 | ||||
| Package | 00810020360738 | GS1 | Inner Pack | 1 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K193411 | 000 |